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 SEG-GU-81330

Objectives

I.  Evaluate the efficacy of cyclophosphamide/diethylstilbestrol vs. 
diethylstilbestrol alone in increasing the disease-free interval in prostate 
cancer patients who have had radical prostatectomy, external beam 
radiotherapy, or I-125 implants.
II.  Evaluate the efficacy of this adjuvant chemotherapy in increasing patient 
survival.
III.  Identify node-negative patients who have received the primary local 
therapy, and follow them for local recurrence, distant metastases, and 
morbidity.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed prostatic cancer of clinical Stage A2, B, or C or an elevated serum 
acid phosphatase and clinical Stage A2, B, or C.  There may be no detectable 
metastasis outside of the pelvic lymph nodes, and bone scan must be negative.  
There may have been no other malignancies (except basal or squamous cell skin 
cancer) within 5 years of study.  Patients may not have had prior hormonal or 
cytotoxic chemotherapy, and must have adequate bilirubin, granulocytes, and 
platelets.

Expected Enrollment

An accrual of 166 node-positive patients (83 per arm) is required.  Accrual 
time is estimated at 2-3 years.  Protocol closed November 1983.

Outline

Randomized study.  Patients initially undergo radical pelvic lymphadenectomy 
and are assigned to Regimen A, B, or C.  Following this treatment, patients 
with positive nodes will be stratified and randomized between Arms I and II; 
patients with negative nodes will be stratified and followed.
Regimen A:  Surgery.  Radical perineal or retropubic prostatectomy.
Regimen B:  Isotopic Radiotherapy.  X-rays from I-125 implant.
Regimen C:  External-beam Radiotherapy.  Co60 or generators with peak photon 
energy of 4 MeV or more.
Arm I:  Single-agent Chemotherapy plus Hormone Therapy.  Cyclophosphamide, 
CTX, NSC-26271; plus Diethylstilbestrol, DES, NSC-3070.
Arm II:  Single-agent Hormone Therapy.  DES.

Trial Contact Information

Trial Lead Organizations

Southeastern Cancer Study Group

George A. Omura, MD, Protocol chair		Ph: 205-444-4617