Status:
COMPLETED
Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 patie...
Detailed Description
OBJECTIVES: Primary * Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride. * Eval...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00403000
Start Date
December 1 2004
End Date
April 1 2013
Last Update
May 1 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001