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 Completed 40 to 85 FCCC-86814 NCI-V87-0282

Objectives

I.  Compare, in a double-blind randomized Phase III trial, the therapeutic 
efficacy and tolerance of leuprolide/anandron vs. leuprolide/placebo in 
patients with Stage D2 prostatic carcinoma.
II.  Determine and compare time to progression, survival, clinical response, 
pain, and performance in the two treatment groups.
III.  Evaluate the long-term safety of anandron in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 40 to 85 years who 
present with newly diagnosed, histologically confirmed Stage D2 carcinoma of 
the prostate and who are willing to accept treatment with leuprolide.  
Patients must not have received previous systemic chemotherapy or endocrine 
therapy, including hormonal therapy, orchiectomy, hypophysectomy, and 
adrenalectomy.  They may have been treated by prostatectomy for initially 
diagnosed localized prostate cancer, and they may have received previous 
radiotherapy of the primary tumor provided there are evaluable sites of active 
disease outside the radiotherapy ports.  There must be no rapidly progressing 
life-threatening illness other than carcinoma of the prostate, and the minimum 
life expectancy is 3 months.  Patients with another neoplasm, aside from 
nonmelanomatous skin cancer, are excluded.  There may be no sensitivity to any 
contrast agent used in radiologic evaluation, and patients must not have other 
medical conditions or a requirement for a medication that might interfere with 
interpretation of efficacy or tolerance.  Liver and kidney function must be 
adequate as evidenced by the following:  serum bilirubin not greater than 2.0 
mg/dl and transaminases not more than 3 times the upper limit of normal, 
except in the presence of hepatic metastases; BUN not over 40 mg/dl and serum 
creatinine not over 2.0 mg/dl, unless solely related to the prostatic tumor.

Expected Enrollment

200 patients will be entered on each arm over about 9 months.

Outline

Double-blind, randomized study.
Arm I:  Endocrine Therapy.  Releasing Factor Agonist plus Antiandrogen.  
Leuprolide, LEUP, NSC-377526; plus RU 23908, Anandron, ANAN.
Arm II:  Endocrine Therapy.  Releasing Factor Agonist plus Placebo.  LEUP; 
plus Placebo.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Richard Greenberg, MD, Protocol chair		Ph: 215-728-5341; 888-369-2427 Email: re_greenberg@fccc.edu