Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed no age specified NPCTG-1600

Objectives

I.  Compare, in a 4-arm randomized Phase III study, the therapeutic efficacy 
of megestrol acetate vs. megestrol acetate plus low-dose diethylstilbestrol 
vs. stilphostrol vs. streptozotocin in patients with advanced carcinoma of the 
prostate who have received extensive radiotherapy, including at least 2,000 
rads to the pelvis or lumbosacral region.
II.  Study the sequential effects of these agents by a crossover design at 
progression.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed cancer of the prostate with documented metastases who have relapsed 
or have been unresponsive to orchiectomy.  Patients must have relapsed after 
any prior estrogen therapy.  Patients may have had prior adrenalectomy or 
hypophysectomy.  The expected survival must be at least 90 days.  Patients may 
not have had any previous cytotoxic chemotherapy, but they must have had 
extensive radiotherapy, including at least 2,000 rads to the pelvis or 
lumbosacral region.  All hormonal therapy must have ceased at least 14 days 
prior to entry, and patients must have recovered from the effects of major 
surgery and be free of significant infection.  Liver and bone marrow function 
must be adequate, and there may be no medically untreatable disease.  There 
may be no history of another neoplasm, with the exception of nonmelanomatous 
skin cancer, and there may be no history of prior treatment with any of the 
study agents.

Expected Enrollment

103 patients will be entered on each arm over approximately 3 years.  Protocol 
closed July 1985.

Outline

Randomized study.
Arm I:  Endocrine Therapy.  Megestrol acetate, MEG, NSC-71423.
Arm II:  Endocrine Therapy.  MEG; plus Diethylstilbestrol, DES, NSC-3070.
Arm III:  Endocrine Therapy.  Stilphostrol, STP, NSC-10481.
Arm IV:  Single-agent Chemotherapy.  Streptozotocin, STZ, NSC-85998.

Trial Contact Information

Trial Lead Organizations

National Prostate Cancer Treatment Group

David McLeod, MD, JD, FACS, Protocol chair		Ph: 202-782-6408 Email: david.mcleod@na.amedd.army.mil