Phase 4 Prostate Cancer Trial, Recruiting NCT06733350 Sponsor: Roswell Park Cancer Institute Condition: Prostate Cancer
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Phase 4 Prostate Cancer Trial, Recruiting

NCT06733350
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men aged 18 years or older
  • Men who have been diagnosed with localized prostate cancer that falls into the very low, low, or favorable intermediate risk categories according to NCCN guidelines, and whose cancer is being managed with active surveillance (monitoring rather than immediate treatment)
  • Men who are able to understand the study's investigational nature and are willing to sign a written consent form approved by an ethics committee before any study procedures begin

Who may not be able to join:

  • Men whose localized prostate cancer falls into the unfavorable intermediate, high, or very high-risk categories according to NCCN guidelines
  • Men being considered for the testosterone replacement therapy (TRT) group who have any of the following: prostate cancer that has spread beyond the prostate or to other parts of the body; male breast cancer; an active wish to father children; blood thickness levels above certain thresholds (confirm with trial site); poorly controlled or uncontrolled heart failure; a urinary symptom score above 19 on a standard prostate symptom questionnaire; or a family history of blood clots in the veins
  • Men who are unwilling or unable to follow the study's required procedures and schedule
  • Men whose overall health or circumstances are considered by the study doctor to make them unsuitable for participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Roswell Park Cancer Institute
Registry
ClinicalTrials.gov
Start date
15 January 2025
Est. completion
15 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Gleason grade progression; Discontinuation of active surveillance; International Prostate Symptom Score (Quality-of-life); Sexual Health Inventory for Men score (Quality-of-life)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov