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NCT Number: NCT00668642

Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University Medical Center, Chicago, Illinois, United States

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About this study

We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven prostate cancer
  • Patients are hormone-naive
  • Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
  • Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
  • Must have an intact prostate (no previous surgery or XRT)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Recovery from any major infection or surgical procedure
  • Signed informed consent

Exclusion criteria

  • Known intolerance or allergy to dutasteride
  • Concomitant chemotherapy, biologic therapy, or XRT to prostate
  • Bilateral orchiectomy
  • Prior malignancy within 5 years of registration

Treatment and study plan

dutasteride

Drug

0.5 mg capsule given orally on daily basis

Other names: Avodart

Placebo

Drug

Identical placebo

Primary outcomes

  1. Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.

    Time frame: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)

    Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.

Secondary outcomes

  1. Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle

    Time frame: At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)

    Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Northwestern University
  • University of Chicago

Registry information

Official study title

Effect of Dutasteride on Androgen-Response Gene Expression During the Tumor Regrowth Phase of Intermittent Androgen Ablation Therapy in Patients With Advanced Prostate Cancer

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2008
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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