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NCT06733350 · ClinicalTrials.gov registry record · Phase 4
Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
A Phase 4 study, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
NCT06733350: Recruiting Phase 4 study, sponsored by Roswell Park Cancer Institute.
NCT06733350 is a Phase 4 study that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 600 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06733350, a Phase 4 study, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The Gleason grade progression will be summarized by group using standard Kaplan-Meier methods, where estimates of the median or specified rates will be obtained. Comparisons will be made between groups using the log-rank test. As exploratory analyses, Cox regression models may be considered to adjust for relevant demographic or clinical confounders. The Bonferroni method will be used to control the family-wise error rate at 0.10.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- OTHER Questionnaire Administration
- PROCEDURE Biopsy of Prostate
- OTHER Patient Observation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 4 |
What NCT06733350 shows while recruiting
NCT06733350 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06733350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06733350 about?
NCT06733350 is a clinical study titled "Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance". 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 pati...
What is the current status of trial NCT06733350?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2025-01-15. Estimated completion is 2029-01-15.
What interventions are being tested in trial NCT06733350?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Questionnaire Administration (OTHER), Biopsy of Prostate (PROCEDURE), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT06733350?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06733350's enrollment target sits among peer trials
600 137th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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