Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Roswell Park Cancer Institute

James L. Mohler

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00403000
Information obtained from ClinicalTrials.gov on December 14, 2011

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