RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well dutasteride works in treating patients
with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
- Evaluate the time to disease progression in patients with recurrent prostate cancer
that progressed during androgen-deprivation therapy who are treated with dutasteride.
- Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic
OUTLINE: Patients receive oral dutasteride once daily until disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer
- Asymptomatic progressive disease despite androgen-deprivation therapy
- Progression must occur during androgen-deprivation therapy comprising
orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with
or without antiandrogen AND after antiandrogen withdrawal
- Concurrent LHRH monotherapy (i. e., LHRH analogs, such as leuprolide
acetate or goserelin) required in patients who did not undergo prior
bilateral orchiectomy to assure testicular androgen suppression
- Recurrent disease, as indicated by at least 1 of the following:
- Prostate-specific antigen (PSA) at baseline ≥ 2. 0 ng/mL
- Biopsy-confirmed local recurrence
- Increase in size of measurable lesions on radiographic study
- New lesion on a nuclear bone scan
- Two successive increases in serum PSA measured at least 1 week apart
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9. 0 g/dL
- Bilirubin ≤ 2. 0 mg/dL
- SGOT ≤ 4 times upper limit of normal
- Creatinine ≤ 2. 0 mg/dL
- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior radiotherapy and recovered
- At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide
or nilutamide
- Patients who have previously progressed despite antiandrogen withdrawal and who
have started antiandrogens without reduction of serum PSA are eligible without
requiring a 28- or 42-day washout interval after antiandrogen withdrawal
- No other prior systemic therapies, except androgen-deprivation therapy (i. e.,
orchiectomy or LHRH analogues only) or antiandrogens
- Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not
considered systemic therapies
- No other concurrent anticancer therapy
- No concurrent use of any of the following:
- Finasteride
- Other investigational 5α-reductase inhibitors
- Anabolic steroids
- Alpha-receptor blockers (e. g., indoramin, tamsulosin hydrochloride, prazosin,
terazosin, alfuzosin hydrochloride, and doxazosin)
- Drugs with antiandrogenic properties (e. g., spironolactone, flutamide,
bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational
agents)
- Products containing selenium ≥ 75 mcg or vitamin E ≥ 100 IU
- Saw palmetto
- EG6761
- No concurrent radiotherapy, including palliative radiotherapy for pain control
