A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial

A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors : A Randomized Trial / Karol M. Pencina, Arthur L. Burnett, Thomas W. Storer, Wen Guo, Zhuoying Li, Adam S. Kibel, Grace Huang, Michelle Blouin, Donna L. Berry, Shehzad Basaria, Shalender Bhasin. - (Journal of Clinical Endocrinology & Metabolism 106 (2021) 8 (August); p. 2171-2186)

  • PMID: 34019661
  • PMCID: PMC8277210 (available on 2022-05-21)
  • DOI: 10.1210/clinem/dgab361


Background: Androgen deficiency is common among prostate cancer survivors, but many guidelines consider history of prostate cancer a contraindication for testosterone replacement. We determined the safety and efficacy of a selective androgen receptor modulator (OPK-88004) in symptomatic, testosterone-deficient men who had undergone radical prostatectomy for low-grade, organ-confined prostate cancer.

Methods: In this placebo-controlled, randomized, double-blind trial, 114 men, ≥19 years of age, who had undergone radical prostatectomy for low-grade, organ-localized prostate cancer, undetectable PSA (<0.1 ng/mL) for ≥2 years after radical prostatectomy and testosterone deficiency were randomized in stages to placebo or 1, 5, or 15 mg OPK-88004 daily for 12 weeks. Outcomes included PSA recurrence, sexual activity, sexual desire, erectile function, body composition, muscle strength and physical function measures, mood, fatigue, and bone markers.

Results: Participants were on average 67.5 years of age and had severe sexual dysfunction (mean erectile function and sexual desire domain scores 7.3 and 14.6, respectively). No participant experienced PSA recurrence or erythrocytosis. OPK-88004 was associated with a dose-related increase in whole-body (P < 0.001) and appendicular (P < 0.001) lean mass and a significantly greater decrease in percent body fat (P < 0.001) and serum alkaline phosphatase (P < 0.001) than placebo. Changes in sexual activity, sexual desire, erectile function, mood, fatigue, physical performance, and bone markers did not differ among groups (P = 0.73).

Conclusions: Administration of OPK-88004 was safe and not associated with PSA recurrence in androgen-deficient men who had undergone radical prostatectomy for organ-confined prostate cancer. OPK-88004 increased lean body mass and decreased fat mass but did not improve sexual symptoms or physical performance.

Original document


Research / Study
21 May 2021
Basaria, Shehzad
Berry, Donna L.
Bhasin, Shalender
Blouin, Michelle
Burnett, Arthur L.
Guo Wen
Huang, Grace
Kibel, Adam S.
Li Zhuoying
Pencina, Karol M.
Storer, Thomas W.
United States of America
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Brigham and Women's Hospital (BWH)
Johns Hopkins University
University of Washington (UW)
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S1. Anabolic Agents
Selective androgen receptor modulators (SARMs)
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Legitimate Medical Treatment
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Scientific article
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Date generated
28 October 2021
Date of last modification
3 November 2021
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