Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Inclusion Criteria

• •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