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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: dutasteride

Study type

Interventional

Funder types

Other

Identifiers

NCT00403000

CDR0000514492

RPCI-I-34904

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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