Testosterone therapy for men with low testosterone and localized prostate cancer on active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV trial investigates the effects of testosterone replacement therapy (TRT) on hypogonadal men with localized prostate cancer who are undergoing active surveillance. The study aims to assess the impact of TRT on cancer progression, quality of life, and the likelihood of discontinuing active surveillance due to adverse effects. Participants will be monitored through regular blood tests, MRI scans, and questionnaires to evaluate changes in symptoms and cancer markers over time. The trial seeks to determine if TRT can improve the quality of life for these patients without exacerbating their cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men aged ≥ 18 years
* Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \[NCCN\] very low, low, and intermediate favorable risk group)
* Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
* For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,

  * Locally advanced or metastatic prostate cancer
  * Male breast cancer
  * Men with an active desire to have children
  * Hematocrit levels \> 54% or baseline hematocrit of 48-50%
  * Uncontrolled or poorly controlled congestive heart failure
  * IPSS (International Prostate Symptom Score) score \> 19
  * Family history of venous thromboembolism
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Ahmed Aly — Roswell Park Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.