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Trial record 62 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403000
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: dutasteride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy
Study Start Date : December 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Dutasteride

Intervention Details:
  • Drug: dutasteride

Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: Every 12 weeks ]
  2. Toxicity [ Time Frame: Daily while on Treatment ]

Secondary Outcome Measures :
  1. Objective response (complete and partial) rate and serum prostate-specific antigen levels [ Time Frame: Every 4 weeks ]
  2. Survival [ Time Frame: Every 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403000

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

Publications of Results:
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00403000     History of Changes
Other Study ID Numbers: CDR0000514492
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013
Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer
Additional relevant MeSH terms:
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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
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists