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Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 12 wordsv5
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v4
  3. Trial status: Recruiting to Suspended Sponsor's reason: Implementation issues
    • Site details revised
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jan 1, 2029 to Jan 15, 2029
    • Start date changed from estimate of Jan 1, 2025 to Jan 15, 2025
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.
Trial Details
NCT Number NCT06733350
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)		 Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov