H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols

CLINICAL RESEARCH PROTOCOLS FOR PROSTATE CANCER


This list of clinical research protocols relating to prostate cancer is compiled for your convenience.

    VA-CSP-407, NCI-T94-0131O, PIVOT-1, CLB-9492 High Priority Clinical Trial Phase III Randomized Study of Prostatectomy vs Expectant Observation With Palliative Therapy for Stage I/II Prostate Cancer (PIVOT).

    Chairperson: Timothy James Wilt. Telephone: 612-725-2000, ext 2681. Lead organization: Veterans Administration Cooperative Studies Program Coordinating Center. Age range: 75 and under.

    RPCI-DS-95-35, NCI-G97-1352 Phase III Study of Epidural Hydromorphone vs Intravenous Hydromorphone in Postoperative Radical Prostatectomy Patients.

    Chairperson: Robert P. Sands, Jr. Telephone: 716-845-8630. Lead organization: Roswell Park Cancer Institute. Age range: 18-70.

    MRC-PR05, EU-94033 Phase III Randomized Double-Blind Study of Clodronate vs Placebo in Patients With Prostate Cancer Metastatic to Bone Who Are Commencing or Responding to Initial Hormone Therapy.

    Chairperson: David P. Dearnaley. Telephone: 0181-642-6011 (England). Lead organization: United Kingdom Medical Research Council. Age range: any age.

    PROG-9509 Phase III Randomized Study of Conventional vs High-Dose Radiotherapy Using Conformal Photons With a Proton Boost in Stage I/II Prostate Cancer.

    Chairperson: Anthony L. Zietman. Telephone: 617-726-8150. Lead organization: Proton Radiation Oncology Group. Age range: any age.

    MSKCC-97007, NCI-G97-1232 Phase II/III Diagnostic Study of C11-Methionine and 2-F18-Fluoro-2-deoxy-D-Glucose (FDG) Positron Emission Tomography (PET) Imaging in Patients With Progressive Prostate Cancer.

    Chairperson: Steven M. Larson. Telephone: 212-639-7373. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: not specified.

    CWRU-1894, NCI-G97-1360 Phase III Study of Adjuvant Estramustine and Etoposide vs Observation Following Radical Prostatectomy for Stage II, III, or IV Prostate Cancer.

    Chairperson: Cindy Connell. Telephone: 216-844-3180. Lead organization: Ireland Cancer Center at Case Western Reserve University. Age range: 18-70.

    AG-3340-009 Phase III Randomized Study of Matrix Metalloproteinase Inhibitor AG3340 in Combination With Mitoxantrone and Prednisone in Patients With Hormone Refractory Prostate Cancer.

    Chairperson: Mary Collier. Telephone: 619-622-8036. Lead organization: Agouron Pharmaceuticals, Inc. Age range: 18 and over.

    CLB-9583 Phase III Randomized Study of Antiandrogen Withdrawal Alone vs Antiandrogen Withdrawal Plus Ketoconazole and Hydrocortisone for Hormone-Refractory Prostate Cancer.

    Chairperson: Eric J. Small. Telephone: 415-885-3780. Lead organization: Cancer and Leukemia Group B. Age range: any age.

    CAN-OCOG-V95-0687, NCI-V95-0687, CAN-NCIC-PR5 Phase III Randomized Study of a Standard vs Shortened Radiotherapy Fractionation Schedule for Localized Prostate Cancer.

    Chairperson: Himu R. Lukka. Telephone: 905-387-9495. Lead organization: Ontario Clinical Oncology Group. Age range: any age.

    MRC-RT01, EU-98005 Phase III Randomized Comparison Study of Conformal Standard Radiotherapy vs Conformal High Dose Radiotherapy in Addition to Neoadjuvant Androgen Deprivation in Patients With Localized Prostate Cancer.

    Chairperson: David P. Dearnaley. Telephone: 0181-642-6011 (England). Lead organization: United Kingdom Medical Research Council. Age range: not specified.

    MSKCC-98014, NCI-G98-1445 Phase III Randomized Study of the Effect of a Diet Low in Fat and High in Soy, Fruits, Vegetables, Green Tea, Vitamin E, and Fiber on PSA Levels in Patients With Prostate Cancer.

    Chairperson: Moshe Shike. Telephone: 212-639-7230. Lead organization: Memorial Sloan-Kettering Cancer Center. Age range: 18 and over.

    MDA-DM-95231, NCI-G96-1044 Phase III Study of Chemo/ Hormonal Therapy vs Androgen Ablation Alone as Initial Therapy in Unresectable/Metastatic Adenocarcinoma of the Prostate.

    Chairperson: Randall E. Millikan. Telephone: 713-792-2830. Lead organization: University of Texas M.D. Anderson Cancer Center. Age range: no age specified.

    E-8892, CLB-E8892 Phase III Randomized Study of Orchiectomy or LHRH Analogue Plus Flutamide With vs Without Suramin and Hydrocortisone in Advanced Adenocarcinoma of the Prostate.

    Chairperson: Robert L. Comis. Telephone: 215-893-6440. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

    CLB-9480, INT-0159, SWOG-9452 Phase III Randomized Study of Low- vs Intermediate- vs High-Dose Suramin for Advanced Hormone-Refractory Prostate Cancer.

    Chairperson: Richard L. Schilsky. Telephone: 773-702-6180. Lead organization: Cancer and Leukemia Group B. Age range: 18 and over.

    CAN-NCIC-PR3, NCI-T94-0110O, E-JPR03 Phase III Randomized Study of Total Androgen Blockade With vs Without Pelvic Irradiation for Stage T3-4, N0, M0 Adenocarcinoma of the Prostate.

    Chairperson: Padraig R. Warde. Telephone: 416-946-2122. Lead organization: NCIC-Clinical Trials Group. Age range: under 80.

    EORTC-30846 Phase III Immediate vs Delayed Endocrine Therapy With Zoladex and Cyproterone Acetate for Patients With pN1-3M0 Carcinoma of the Prostate.

    Chairperson: Fritz H. Schroeder. Telephone: 31-10-4633607 (Netherlands). Lead organization: EORTC Genito-Urinary Tract Cancer Cooperative Group. Age range: any age.

    EORTC-30921 Phase III Randomized Trial of Strontium-89 vs Palliative Local Radiotherapy in Patients With Hormone-Refractory Prostate Cancer With Painful Osseous Metastases.

    Chairperson: G.O.N. Oosterhof. Telephone: 31-24-3616712 (Netherlands). Lead organization: EORTC Genito-Urinary Tract Cancer Cooperative Group. Age range: any age.

    EORTC-30972 Phase III Randomized Study of Prednisone Alone or in Combination With BMS-182751 in Patients With Advanced Hormone Refractory Adenocarcinoma of the Prostate.

    Chairperson: Cora N. Sternberg. Telephone: 011-39-6-5240-6812 (Italy). Lead organization: EORTC Genito-Urinary Tract Cancer Cooperative Group. Age range: over 18.

    EORTC-30891 Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate.

    Chairperson: Urs E. Studer. Telephone: 031-632-3621 (Switzerland). Lead organization: EORTC Genito-Urinary Tract Cancer Cooperative Group. Age range: 80 and under.

    CAN-NCIC-PR6 Phase III Randomized Study of Mitoxantrone and Prednisone With or Without Clodronate in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain.

    Chairperson: D. Scott Ernst. Telephone: 403-670-1761. Lead organization: NCIC-Clinical Trials Group. Age range: any age.

    EORTC-22961 Phase III Study of Long Term Adjuvant Hormonal Treatment With LHRH Analogue (Goserelin) vs No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Month Combined Androgen Blockade.

    Chairperson: Michel Bolla. Telephone: 33 476765506 (France). Lead organization: EORTC Radiotherapy Cooperative Group. Age range: any age.

    EORTC-22911 Phase III Randomized Study of Postoperative External Radiotherapy vs No Immediate Further Treatment in Patients With pT3 pN0 Prostatic Adenocarcinoma.

    Chairperson: Michel Bolla. Telephone: 33 476765506 (France). Lead organization: EORTC Radiotherapy Cooperative Group. Age range: 75 and under.

    SWOG-9346, CLB-9594, INT-0162, E-S9346 Phase III Randomized Study of Intermittent vs Constant Combined Androgen Deprivation (Flutamide/Leuprolide or Flutamide/Goserelin) in Stage D2 Prostate Cancer Responsive to Such Therapy.

    Chairperson: Maha Hadi A. Hussain. Telephone: 313-745-4700. Lead organization: Southwest Oncology Group. Age range: adult.

    RTOG-9601, RTOG-R9601, SWOG-R9601 Phase III Randomized, Double-Blind Study of Radiotherapy With vs Without Bicalutamide in Patients With PSA Elevation Following Radical Prostatectomy for pT3 N0 Carcinoma of the Prostate.

    Chairperson: William U. Shipley, Telephone: 617-726-8146. Lead organization: Radiation Therapy Oncology Group. Age range: any age.

    RTOG-9608 Phase III Study of Total Androgen Suppression vs Total Androgen Suppression Plus Definitive External Beam Irradiation for Pathologic Lymph Node Positive Adenocarcinoma of the Prostate.

    Chairperson: Colleen A. Lawton. Telephone: 414-257-5726. Lead organization: Radiation Therapy Oncology Group. Age range: not specified.

    RTOG-9714, NCI-P97-0124, NCCTG-R9714 Phase III Randomized Study of Palliative Radiation Therapy for Bone Metastases From Breast or Prostate Cancer.

    Chairperson: William F. Hartsell. Telephone: 708-723-8030. Lead organization: Radiation Therapy Oncology Group. Age range: 18 and over.

    RTOG-9413 Phase III Randomized Study of Whole-Pelvic Irradiation Followed by a Cone-Down Boost to the Prostate vs Prostate Irradiation Only and of Neoadjuvant vs Adjuvant FLUT/ZDX for Adenocarcinoma of the Prostate.

    Chairperson: Mack Roach, III. Telephone: 415-476-4815. Lead organization: Radiation Therapy Oncology Group. Age range: any age.

    RTOG-9408 Phase III Randomized Study of Radiotherapy With vs Without Neoadjuvant Flutamide/ Goserelin in Good-Prognosis, Locally Confined Adenocarcinoma of the Prostate.

    Chairperson: David G. McGowan. Telephone: 403-432-8771. Lead organization: Radiation Therapy Oncology Group. Age range: any age.

Legend for Abbreviations:

AG = Agouron Pharmaceuticals, Inc
CAN-NCIC = National Cancer Institute of Canada
CAN-OCOG = Ontario Clinical Oncology Group
CLB = Cancer & Leukemia Group B
CWRU = Case Western Reserve University
E, EST = Eastern Cooperative Oncology Group
EORTC = European Organization for Research on Treatment of Cancer
MDA = M.D. Anderson Cancer Center
MRC = United Kingdom Medical Research Council
MSKCC = Memorial Sloan-Kettering Cancer Center
PROG = Proton Radiation Oncology Group
RPCI = Roswell Park Cancer Institute
RTOG = Radiation Therapy Oncology Group
SWOG = Southwest Oncology Group
VA = Veterans Administration Cooperative Studies Program


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