Contents:

Prostate Cancer Opinion Leader Forum(2002 Edition) Table of Contents DISCLAIMER .......................................................................................................................................................... i THERAPEUTIC OVERVIEW................................................................................................................................. v I. GENERAL ISSUES IN THE MANAGEMENT OF PROSTATE CANCER AND BENIGN PROSTATIC HYPERPLASIA (BPH) ......................................................................................... 1 1. THE PROSTATE........................................................................................................................................ 1 2. PROSTATE CANCER ............................................................................................................................... 1 2.1 Understanding the cancer process .................................................................................................... 1 2.2 Prostate cancer: who’s at risk? ......................................................................................................... 2 2.3 Detecting prostate cancer ................................................................................................................. 2 2.4 Recognizing symptoms .................................................................................................................... 2 2.5 Diagnosing prostate cancer............................................................................................................... 3 2.6 Stages and grading of prostate cancer .............................................................................................. 3 2.6.1 Staging prostate cancer......................................................................................................................................3 2.6.2 Grading prostate cancer .....................................................................................................................................4 2.6.3 The combined Gleason Score or Gleason Sum..................................................................................................5 2.6.4 What does the Gleason Score mean? .................................................................................................................6 2.7 Treatment for prostate cancer ........................................................................................................... 6 2.7.1 Preparing for treatment ......................................................................................................................................6 2.7.2 Methods of treatment.........................................................................................................................................7 2.7.3 Adverse effects of treatment ..............................................................................................................................8 2.7.4 Watchful waiting ...............................................................................................................................................8 2.7.5 Surgery ..............................................................................................................................................................8 2.7.6 Radiation therapy...............................................................................................................................................8 2.7.7 Hormonal therapy..............................................................................................................................................9 2.7.8 Support for men with prostate cancer ................................................................................................................9 2.8 Ongoing research in the diagnosis and management of prostate cancer........................................... 9 2.8.1 Causes of prostate cancer...................................................................................................................................9 2.8.2 Prevention of prostate cancer.............................................................................................................................9 2.8.3 Screening/early detection.................................................................................................................................10 2.8.4 Treatment.........................................................................................................................................................10 2.9 Prostate cancer incidence and risk factors ...................................................................................... 10 3. BPH ........................................................................................................................................................ 11 3.1 Diagnosing BPH............................................................................................................................. 12 3.2 Treating BPH.................................................................................................................................. 12 3.2.1 Watchful waiting .............................................................................................................................................12 3.2.2 BPH surgery ....................................................................................................................................................13 3.2.2.1 Transurethral resection of the prostate (TURP)..........................................................................................13 3.2.2.2 Transurethral incision of the prostate (TUIP).............................................................................................13 3.2.2.3 Transurethral needle ablation (TUNA).......................................................................................................14 3.2.2.4 Open prostatectomy....................................................................................................................................14 3.2.3 BPH drug therapy ............................................................................................................................................14 3.2.4 Choosing a treatment for BPH.........................................................................................................................15 II. CLINICAL MANAGEMENT OF PROSTATE CANCER AND BENIGN PROSTATIC HYPERPLASIA (BPH)................................................................................................................ 17 1. PROSTATE CANCER ............................................................................................................................. 17 1.1 Pharmaceutical strategies for managing prostate cancer ................................................................ 17 1.1.1 Chemotherapy..................................................................................................................................................17 1.1.2 Hormone therapy .............................................................................................................................................17 1.1.3 Immunotherapy................................................................................................................................................18 1.1.4 Vaccines ..........................................................................................................................................................18 1.1.5 Cell cycle regulators ........................................................................................................................................18 1.2 Patient care strategies for managing prostate cancer ...................................................................... 19 1.2.1 Challenges in the management of prostate cancer ...........................................................................................19 1.2.2 Is the prostate knowledge base behind the curve? ...........................................................................................21 1.2.3 Do we know if certain treatments prolong life or increase quality of life? ......................................................22 1.2.4 Screening for prostate cancer and the PSA test ...............................................................................................24 1.2.5 Treatment options for prostate cancer..............................................................................................................26 1.2.5.1 Watchful waiting ........................................................................................................................................26 1.2.5.2 Hormone therapy........................................................................................................................................27 1.2.5.3 Possible adverse effects of hormone therapy:.............................................................................................27 1.2.5.4 Selected experts’ comments on hormonal therapy .....................................................................................28 1.2.5.5 Chemotherapy ............................................................................................................................................29 1.2.5.6 Selected experts’ comments on chemotherapy...........................................................................................29 1.2.5.7 Radiation therapy .......................................................................................................................................30 1.2.5.8 Possible adverse effects of radiation treatment...........................................................................................31 1.2.5.9 Selected experts’ comments about radiation therapy..................................................................................31 1.2.5.10 Surgical interventions in the management of prostate cancer.....................................................................32 1.2.5.11 Selected experts’ comments about radical prostatectomy ..........................................................................34 1.2.5.12 Cryosurgery................................................................................................................................................35 1.2.5.13 Endocare, Inc. – a perspective on cryosurgery ...........................................................................................35 1.2.5.14 The case for conservative treatment in the management of prostate cancer ...............................................37 1.2.5.15 A unique twist in E-health..........................................................................................................................38 2. BPH .........................................................................................................................................................................40 2.1 The challenge in managing BPH.................................................................................................... 40 2.2 Pharmaceutical strategies for BPH................................................................................................. 40 2.3 Patient care strategies for managing BPH...................................................................................... 41 2.3.1 Early diagnosis ................................................................................................................................................41 2.3.2 The BPH knowledge base................................................................................................................................41 2.3.3 Surgery ............................................................................................................................................................42 2.3.3.1 Selected experts' comments regarding procedures used to manage BPH...................................................43 III. PRODUCT DEVELOPMENT ISSUES IN THE MANAGEMENT OF PROSTATE CANCER AND BENIGN PROSTATIC HYPERPLASIA (BPH) ........................................... 45 1. PROSTATE CANCER ............................................................................................................................. 45 1.1 Introduction .................................................................................................................................... 45 1.1.1 Current treatment.............................................................................................................................................45 1.1.1.1 Chemotherapy ............................................................................................................................................45 1.1.1.2 Hormone Therapy ......................................................................................................................................45 1.1.1.3 Immunotherapy ..........................................................................................................................................46 1.1.1.4 Cell cycle regulators...................................................................................................................................46 1.1.1.5 Surgery and radiation therapy ....................................................................................................................46 1.2 Prevention of prostate cancer ......................................................................................................... 46 1.2.1 Prostate cancer prevention trial (PCPT) ..........................................................................................................46 1.2.2 Selenium and vitamin E cancer prevention trial (SELECT Trial)....................................................................48 1.3 PIVOT Trial ................................................................................................................................... 50 1.4 New diagnostic markers for the detection of prostate cancer ......................................................... 51 1.4.1 Matritech unveils new advance in detecting prostate cancer ...........................................................................53 1.5 Future therapeutics for the management of prostate cancer ........................................................... 55 1.5.1 Chemotherapy..................................................................................................................................................55 1.5.2 Hormone therapy .............................................................................................................................................56 1.5.3 Immunotherapy................................................................................................................................................56 1.5.4 Cell cycle regulators ........................................................................................................................................56 1.6 Selected experts’ comments on drug development for the management of prostate cancer.......... 56 1.7 Product development in radiation therapy...................................................................................... 64 1.8 Nutritional therapy for the prevention of prostate cancer............................................................... 67 2. BPH ........................................................................................................................................................ 69 2.1 Introduction .................................................................................................................................... 69 2.1.1 BPH therapy options include watchful waiting, medications, and surgery......................................................70 2.2 Therapeutics for managing BPH .................................................................................................... 71 2.3 Other approaches to managing BPH .............................................................................................. 72 IV. NEED GAPS IN THE MANAGEMENT OF PROSTATE CANCER.................................... 75 3. BIOLOGY, PROGRESSION, AND METASTASIS ............................................................................... 76 4. ETIOLOGY AND PRIMARY PREVENTION........................................................................................ 77 4.1 Early detection, diagnosis, and prognosis ...................................................................................... 78 4.2 Staging and treatment of localized prostate cancer ........................................................................ 80 4.3 Systemic therapies.......................................................................................................................... 82 5. OUTCOMES RESEARCH....................................................................................................................... 84 V. PROFILES OF LEADING FIRMS DEVELOPING AND/OR MARKETING PROSTATE CANCER AND BENIGN PROSTATIC HYPERPLASIA (BPH) MEDICATIONS ............. 85 1. ABBOTT................................................................................................................................................... 85 1.1 Executive summary ........................................................................................................................ 85 1.2 Urology products............................................................................................................................ 86 1.3 Prostate cancer products ................................................................................................................. 86 1.4 Prostate cancer pipeline.................................................................................................................. 86 2. ALZA CORPORATION........................................................................................................................... 87 2.1 Prostate cancer pipeline.................................................................................................................. 88 3. AMERICAN HOME PRODUCTS........................................................................................................... 88 3.1 Executive summary ........................................................................................................................ 88 3.2 Prostate cancer products ................................................................................................................. 89 4. AMGEN.................................................................................................................................................... 89 4.1 Executive summary ........................................................................................................................ 89 4.2 Prostate cancer pipeline.................................................................................................................. 90 5. ASTRAZENECA...................................................................................................................................... 90 5.1 Executive summary ........................................................................................................................ 90 5.2 Prostate cancer pipeline.................................................................................................................. 91 6. AVENTIS.................................................................................................................................................. 91 6.1 Executive summary ........................................................................................................................ 91 6.2 Prostate cancer products ................................................................................................................. 92 6.3 BPH products ................................................................................................................................. 92 6.4 Prostate cancer pipeline.................................................................................................................. 92 7. BARR LABORATORIES ........................................................................................................................ 93 7.1 Executive summary ........................................................................................................................ 93 7.2 Prostate cancer products ................................................................................................................. 94 7.3 Prostate cancer pipeline.................................................................................................................. 94 8. BAYER..................................................................................................................................................... 94 8.1 Executive summary ........................................................................................................................ 94 8.2 Prostate cancer products ................................................................................................................. 95 9. ELAN ........................................................................................................................................................ 95 9.1 Executive summary ........................................................................................................................ 95 9.2 Prostate cancer pipeline.................................................................................................................. 96 9.3 Collaborations ................................................................................................................................ 96 10. GENENTECH........................................................................................................................................... 96 10.1 Executive summary ........................................................................................................................ 96 10.2 Prostate cancer pipeline.................................................................................................................. 97 11. GLAXOSMITHKLINE ............................................................................................................................ 97 11.1 Executive summary ........................................................................................................................ 97 11.2 BPH pipeline .................................................................................................................................. 98 12. IDEC PHARMACEUTICALS ................................................................................................................. 98 12.1 Executive summary ........................................................................................................................ 98 12.2 Prostate cancer pipeline.................................................................................................................. 98 12.3 Prostate cancer collaborations ........................................................................................................ 99 13. IMMUNEX............................................................................................................................................... 99 13.1 Executive summary ........................................................................................................................ 99 13.2 Prostate cancer products ................................................................................................................. 99 13.3 Prostate cancer pipeline.................................................................................................................. 99 13.4 Prostate cancer collaborations ...................................................................................................... 100 14. IVAX CORPORATION ......................................................................................................................... 100 14.1 Executive summary ...................................................................................................................... 100 14.2 Benign prostatic hyperplasia products.......................................................................................... 101 14.3 Prostate cancer products ............................................................................................................... 101 15. JOHNSON & JOHNSON ....................................................................................................................... 101 15.1 Executive summary ...................................................................................................................... 101 15.2 Recent acquisitions....................................................................................................................... 101 15.3 Prostate cancer products ............................................................................................................... 101 15.4 Prostate cancer pipeline................................................................................................................ 102 15.5 BPH pipeline ................................................................................................................................ 102 16. MERCK & CO........................................................................................................................................ 102 16.1 Executive summary ...................................................................................................................... 102 16.1.1 Benign prostatic hyperplasia products ...........................................................................................................102 17. MERCK GROUP.................................................................................................................................... 103 17.1 Executive summary ...................................................................................................................... 103 17.2 Prostate cancer collaborations ...................................................................................................... 103 18. MYLAN LABORATORIES................................................................................................................... 104 18.1 Executive summary ...................................................................................................................... 104 18.2 Benign prostatic hyperplasia products.......................................................................................... 104 19. NOVARTIS ............................................................................................................................................ 104 19.1 Executive summary ...................................................................................................................... 104 19.2 Prostate cancer pipeline................................................................................................................ 105 20. PFIZER ................................................................................................................................................... 106 20.1 Executive summary ...................................................................................................................... 106 20.2 Benign prostatic hyperplasia products.......................................................................................... 106 20.3 Benign prostatic hyperplasia pipeline........................................................................................... 106 20.4 Prostate cancer pipeline................................................................................................................ 107 21. PHARMACIA......................................................................................................................................... 107 21.1 Executive summary ...................................................................................................................... 107 21.2 Prostate cancer products ............................................................................................................... 108 22. ROCHE................................................................................................................................................... 108 22.1 Executive summary ...................................................................................................................... 108 22.2 Prostate Cancer Diagnostics ......................................................................................................... 109 23. SANOFI-SYNTHÉLABO ...................................................................................................................... 109 23.1 Executive summary ...................................................................................................................... 109 23.2 Prostate cancer pipeline................................................................................................................ 110 23.3 Benign prostatic hyperplasia pipeline........................................................................................... 110 24. SCHERING AG...................................................................................................................................... 110 24.1 Executive summary ...................................................................................................................... 110 24.2 Prostate cancer products ............................................................................................................... 111 24.3 Prostate cancer pipeline................................................................................................................ 111 24.4 Prostate cancer diagnostic pipeline............................................................................................... 111 25. TAKEDA................................................................................................................................................ 111 25.1 Executive summary ...................................................................................................................... 111 25.2 Prostate cancer products ............................................................................................................... 112 I APPENDIX – THE CASE AGAINST SCREENING FOR PROSTATE CANCER............ 113 1. BURDEN OF SUFFERING ................................................................................................................... 113 1.1 Accuracy of screening tests .......................................................................................................... 113 1.2 Effectiveness of early detection.................................................................................................... 115 1.3 Recommendations of other groups ............................................................................................... 117 1.4 Discussion .................................................................................................................................... 118 1.5 Clinical intervention ..................................................................................................................... 119 II APPENDIX – THE PUBLIC HEALTH BURDEN OF PROSTATE CANCER .................. 121 1. PRIMARY PREVENTION .................................................................................................................... 121 2. THE CHALLENGE OF EARLY DETECTION .................................................................................... 121 2.1 Screening methods ....................................................................................................................... 121 2.2 Treatment options......................................................................................................................... 122 2.3 When prostate cancer has not spread............................................................................................ 122 2.4 When prostate cancer has spread.................................................................................................. 122 2.5 CDC’s activities targeting prostate cancer ................................................................................... 122 2.6 Using data for prostate cancer prevention and control ................................................................. 123 2.7 Building the science base and educating the public ..................................................................... 123 2.8 Future directions for public health practice and research in prostate cancer ................................ 123 2.9 Turning suggestions into action.................................................................................................... 124 2.10 Taking a comprehensive approach to prostate cancer .................................................................. 125 2.11 Other CDC activities include........................................................................................................ 125 III APPENDIX – SUMMARY OF THE REPORT OF THE PROSTATE CANCER PROGRESS REVIEW GROUP TO THE NATIONAL CANCER INSTITUTE ................ 127 1. INTRODUCTION .................................................................................................................................. 127 1.1 Executive summary ...................................................................................................................... 127 1.2 Biology, progression, and metastasis ........................................................................................... 128 1.2.1 Etiology and primary prevention ...................................................................................................................128 1.2.2 Early detection, diagnosis, and prognosis......................................................................................................129 1.2.3 Laboratory and clinical models......................................................................................................................129 1.2.4 Staging and treatment of localized prostate cancer........................................................................................130 1.2.5 Systemic therapies .........................................................................................................................................130 1.2.6 Outcomes research.........................................................................................................................................131 1.2.7 Resources needed ..........................................................................................................................................131 1.2.8 Conclusions ...................................................................................................................................................132 1.3 Priorities and recommendations ................................................................................................... 132 1.3.1 Biology, progression, and metastasis of prostate cancer................................................................................132 1.3.2 Current status of the field ..............................................................................................................................132 1.3.3 Vision ............................................................................................................................................................134 1.3.4 Challenges and opportunities.........................................................................................................................135 1.4 Research priorities........................................................................................................................ 135 1.4.1 Priority one....................................................................................................................................................135 1.4.2 Priority two....................................................................................................................................................141 1.4.3 Priority three..................................................................................................................................................141 1.5 Etiology and primary prevention.................................................................................................. 142 1.6 Current status of the field ............................................................................................................. 142 1.6.1 Age ................................................................................................................................................................143 1.6.2 Race/ethnicity ................................................................................................................................................143 1.6.3 Family history................................................................................................................................................143 1.6.4 Dietary intakes...............................................................................................................................................144 1.6.5 Androgen production and metabolism...........................................................................................................144 1.6.6 Other factors ..................................................................................................................................................145 1.6.7 Implications for prevention............................................................................................................................145 1.6.8 Vision ............................................................................................................................................................145 1.6.9 Challenges and opportunities.........................................................................................................................146 1.7 Research priorities........................................................................................................................ 147 1.7.1 Priority one....................................................................................................................................................147 1.7.2 Priority two....................................................................................................................................................150 1.7.3 Priority three..................................................................................................................................................150 1.8 Early detection, diagnosis and prevention .................................................................................... 150 1.8.1 Current status of the field ..............................................................................................................................150 1.8.2 Early detection...............................................................................................................................................150 1.8.3 Diagnosis .......................................................................................................................................................151 1.8.4 Prognosis .......................................................................................................................................................152 1.8.5 Vision ............................................................................................................................................................152 1.8.6 Challenges and opportunities.........................................................................................................................152 1.8.7 Research priorities .........................................................................................................................................154 1.8.7.1 Development and validation of additional biologic determinants with prognostic utility ........................154 1.8.7.2 Development and validation of surrogate markers ...................................................................................154 1.8.7.3 Development and validation of molecular assays that can augment or replace tissue-based assays........154 1.8.7.4 Development of computer and mathematical modeling techniques .........................................................154 1.8.7.5 Research in improved body imaging techniques ......................................................................................154 1.8.7.6 Refinement of techniques for computer assisted image analysis..............................................................155 1.8.8 Priority one....................................................................................................................................................155 1.8.9 Priority two....................................................................................................................................................159 1.8.10 Priority three..................................................................................................................................................159 1.9 Laboratory and clinical models .................................................................................................... 160 1.9.1 Current status of the field ..............................................................................................................................160 1.9.2 Vision ............................................................................................................................................................160 1.10 Challenges and opportunities ....................................................................................................... 161 1.10.1 Models that mimic human prostate cancer in initiation, progression and metastasis.....................................161 1.10.2 Use of models in detecting and treating prostate cancer................................................................................162 1.10.3 Use of current models to understand prostate cancer progression and metastasis .........................................162 1.11 Research priorities........................................................................................................................ 162 1.11.1 Priority one....................................................................................................................................................162 1.11.2 Priority two....................................................................................................................................................164 1.11.3 Priority three..................................................................................................................................................164 1.12 Staging and treatment of localized prostate cancer ...................................................................... 164 1.12.1 Current status of the field ..............................................................................................................................164 1.12.2 Vision ............................................................................................................................................................166 1.13 Challenges and opportunities ....................................................................................................... 166 1.13.1 Staging of prostate cancer and indicators (markers) of prognosis or response to therapy in the primary tumor................................................................................................................................................................166 1.13.2 Efficacy of therapy for localized prostate cancer...........................................................................................167 1.13.3 Combination therapy for localized cancer .....................................................................................................168 1.13.4 Gene and cellular therapy ..............................................................................................................................168 1.13.5 Research priorities .........................................................................................................................................169 1.13.6 Priority one....................................................................................................................................................169 1.13.7 Priority two....................................................................................................................................................172 1.13.8 Priority three..................................................................................................................................................173 1.14 Systemic therapy .......................................................................................................................... 173 1.14.1 Current status of the field ..............................................................................................................................173 1.14.2 Vision ............................................................................................................................................................174 1.14.3 Challenges and opportunities.........................................................................................................................175 1.14.4 Research priorities .........................................................................................................................................177 1.14.5 Priority one....................................................................................................................................................177 1.14.6 What is the role of gene and cellular therapy for prostate cancer?.................................................................177 1.14.7 What is the optimal treatment for androgen-independent disease?................................................................178 1.14.8 When should a patient with a rising PSA be treated? ....................................................................................179 1.14.9 How can new targets be identified?...............................................................................................................179 1.14.10 Priority two....................................................................................................................................................179 1.14.11 Priority three..................................................................................................................................................180 1.15 Outcomes research ....................................................................................................................... 180 1.15.1 Current status of the field ..............................................................................................................................180 1.15.2 Vision ............................................................................................................................................................181 1.16 Challenges and opportunities ....................................................................................................... 181 1.17 Research priorities........................................................................................................................ 182 1.17.1 Priority one....................................................................................................................................................182 1.17.2 Priority two....................................................................................................................................................183 1.17.3 Priority three..................................................................................................................................................184 IV APPENDIX – SELECTED RECENT EVENTS IN THE MANAGEMENT OF PROSTATE CANCER AND BENIGN PROSTATIC HYPERPLASIA (BPH) ......................................... 185 1. PROSTATE CANCER ........................................................................................................................... 185 1.1 DOR BioPharma presents advancements of its oral drug/peptide delivery systems at the 6th US- Japan drug delivery symposium.............................................................................................................. 185 1.2 AltaRex prostate cancer antibody data presented at AACR Special Conference ......................... 185 1.3 DGI and Novo Nordisk form new partnership ............................................................................. 186 1.4 Geron Corporation and Genetic Therapy, Inc. partner to develop cancer therapy ....................... 186 1.5 Atrix Licenses additional Leuprogel product to Sanofi-Synthelabo............................................. 187 1.6 Cell Pathways updates status of three CP461 pilot studies .......................................................... 187 1.7 NeoTherapeutics’ NeoOncoRx completes transfer of IND for Satraplatin .................................. 188 1.8 Myriad Genetics submits clinical trial on its lead prostate cancer drug, Flurizan, to the FDA .... 188 1.9 AstraZeneca submits supplemental new drug application to the FDA for Casodex bicalutamide) 150mg for the treatment of early-stage prostate cancer .......................................................................... 189 1.10 Studies with Introgen’s INGN 201 Gene Therapeutic demonstrate activity as an anti-cancer vaccine .................................................................................................................................................... 189 1.11 Novogen anti-cancer drug Phenoxodiol to start clinical trial in patients with leukemia .............. 190 1.12 Cell Genesys updates clinical results of Phase I/II trial of CG7870 in advanced prostate cancer 190 1.13 Abgenix initiates Phase II clinical trial of ABX-EGF in prostate cancer ..................................... 191 1.14 Northwest Biotherapeutics, Inc. to present study of new approach to enhance its DCVax cancer platform................................................................................................................................................... 192 1.15 Keryx Biopharmaceuticals obtains worldwide rights to Novel Small Molecules Technology .... 192 1.16 GenStar’s cancer product suppresses the growth of prostate tumors and enhances the effects of radiation therapy ..................................................................................................................................... 193 1.17 New study reveals fewer complications with SeedNet Technique for Salvage Cryoablation; modified surgical technique is reproducible and easy to learn................................................................ 193 1.18 MED-TEC launches ASAP(TM) prostate seeding needle loading service .................................. 194 1.19 New data report Matritech’s NMP48 prostate cancer blood test more accurate than PSA; NMP48 test could reduce unnecessary biopsies ................................................................................................... 194 1.20 New study shows investigational magnetic resonance imaging contrast agent able to detect lymph node disease in prostate cancer patients .................................................................................................. 195 1.21 Promising new potential screening test for prostate cancer.......................................................... 195 1.22 Prosurg, Inc. receives the FDA marketing clearance for RF gel electrosurgical probes & devices ... ...................................................................................................................................................... 196 1.23 Atrix prostate cancer drug approved ............................................................................................ 196 1.24 Relationship between lifestyle and prostate cancer subject of new study .................................... 197 1.25 Novartis wins US panel backing for new Zometa use.................................................................. 197 1.25.1 Clinical data...................................................................................................................................................197 1.26 Stanford researchers challenge value of widely used prostate cancer diagnostic methods ......... 198 1.27 Cell Genesys receives $6 million payment from GVAX cancer vaccine collaboration .............. 198 1.28 Active Biotech obtains US patent for cancer product................................................................... 199 1.29 Cell Therapeutics, Inc. identifies and validates a novel drug development target linked to a major cancer-causing gene ................................................................................................................................ 199 1.30 Corvas advances anti-cancer drug discovery program on a new family of membrane-bound serine proteases.................................................................................................................................................. 200 2. BENIGN PROSTATIC HYPERPLASIA............................................................................................... 200 2.1 Nymox Alzheimer’s research leads to promising prostate drugs ................................................. 200 2.2 Laserscope announces intermediate results from multi-site clinical evaluation of Niagara PV for BPH ...................................................................................................................................................... 201 V APPENDIX – DICTIONARY OF TERMS USED IN THE MANAGEMENT OF PROSTATE DISORDERS ........................................................................................................ 203 List of Tables Table I – Pharmacologic treatment options for benign prostatic hyperplasia (BPH) ................................ 13 Table II – Medications that can increase the symptoms of benign prostatic hyperplasia (BPH) .............. 14 Table III – Prostate cancer drug development programs......................................................................... 207 Table IV – Benign prostatic hyperplasia (BPH) drug development programs........................................ 211