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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00403000
First received: November 21, 2006
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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
    Oral
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403000

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

Additional Information:
Publications:
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgens
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 20, 2014