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

Condition(s) targeted: Prostate Cancer

Intervention: dutasteride (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
James L. Mohler, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute

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.

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

Study design: Treatment, Open Label

Primary outcome:

Time to disease progression

Toxicity

Secondary outcome:

Objective response (complete and partial) rate and serum prostate-specific antigen levels

Survival

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.

- 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2004
Last updated: May 23, 2008