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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Evaluate the toxicity of dutasteride in these patients. Secondary Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride. Determine the survival of patients treated with dutasteride. Determine the quality of life of patients treated with dutasteride. 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.

Official Title
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Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: dutasteride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dutasteride|Oral|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | Every 12 weeks | 
| Toxicity |  | Daily while on Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response (complete and partial) rate and serum prostate-specific antigen levels |  | Every 4 weeks | 
| Survival |  | Every 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer