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

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
First received: November 21, 2006
Last updated: April 30, 2013
Last verified: April 2013

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.

Condition Intervention Phase
Prostate Cancer
Drug: dutasteride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Time to disease progression [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Daily while on Treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response (complete and partial) rate and serum prostate-specific antigen levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: December 2004
Study Completion Date: April 2013
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dutasteride
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403000

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: James L. Mohler, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00403000     History of Changes
Other Study ID Numbers: CDR0000514492, RPCI-I-34904
Study First Received: November 21, 2006
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014