A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven previously treated adenocarcinoma of the prostate

- Prior definitive therapy must have occurred at least 6 months, but no more than 10
years, prior to study

- Definitive therapy is defined as one of the following:

- Prior radical prostatectomy

- Radiotherapy to the prostate no more than 3 months before prostatectomy

- Brachytherapy

- Brachytherapy with external beam radiotherapy given as single therapy

- External beam radiation therapy alone

- Must have a PSA level between 1-10 nu/mL, with a rise of at least 1 nu/mL above the
nadir produced by definitive therapy

- No evidence of local recurrence

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN

Renal:

- Creatinine no greater than 2 times ULN

Other:

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- At least 2 years since finasteride or other 5a-reductase inhibitors

- At least 12 months since prior hormone therapy for prostate cancer

- No more than 6 months of prior hormone therapy

- No corticosteroids in excess of standard replacement doses

- No concurrent systemic steroids

- No other concurrent antiandrogenic drugs or 5a-reductase inhibitors

Radiotherapy:

- See Disease Characteristics

- No concurrent palliative radiotherapy

Surgery:

- See Disease Characteristics

- No orchiectomy