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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed no age specified MSKCC-90127 NCI-V91-0098

Objectives

I.  Determine whether finasteride vs. placebo decreases PSA levels in patients 
who have undergone a radical prostatectomy for prostate cancer.

Entry Criteria

Disease Characteristics:

Histologically confirmed prostate adenocarcinoma (with or
without positive lymph nodes) treated by radical
prostatectomy within the past 10 years

PSA levels of 1.0-10.0 ng/ml that do not differ by more than
3.0 ng/ml at 1 and 2 weeks prior to entry required

No evidence of skeletal metastases on baseline bone scan

No palpable rectal mass

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No prior endocrine therapy
  No prior hormonal therapy
  No current requirement for conventional hormonal therapy
  No chronic concurrent use of drugs with anti-androgenic
    properties (e.g., cimetidine, spironolactone, flutamide)

Radiotherapy:
  No prior radiotherapy
  No current requirement for radiotherapy

Surgery:
  Prior radical prostatectomy required
  No prior orchiectomy

Other:
  At least 6 months since any prior treatment with
     investigational drugs
  No chronic concurrent use of barbiturates, heparin,
     theophylline, warfarin, or anti-arrhythmic agents (other
     than digoxin and propranolol)

Patient Characteristics:

Age:
  Not specified

Performance status:
  Not specified

Hematopoietic:
  Not specifiec

Hepatic:
  Liver function test no more than 2 x ULN

Renal:
  Creatinine no more than 2.0 mg/dl

Cardiovascular:
  No chronic concurrent use of anti-arrhythmic agents (other
  than digoxin and propranolol)

Other:
  No impending spinal cord compression
  No history of drug or alcohol abuse

Expected Enrollment

40 patients/arm will be studied; approximately 18 months will be required for 
completion of the study.

Outline

Randomized, double-blind study.
Arm I:  Hormonal Therapy.  Finasteride, MK-906.
Arm II:  Control.  Placebo.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

William R. Fair, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-4710; 800-525-2225 Email: fairw@mskcc.org