Testosterone therapy for men with low testosterone and localized prostate cancer on active surveillance
Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
This study is testing if testosterone therapy can help men with low testosterone and localized prostate cancer feel better and stay safe while they are being monitored for their cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06733350 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with localized prostate cancer on active surveillance and low testosterone levels.
Not a fit: Patients with advanced prostate cancer, contraindications to TRT, or those with high-risk cancer profiles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for hypogonadal men with localized prostate cancer by alleviating symptoms associated with low testosterone.
How similar studies have performed: While TRT in prostate cancer patients has been approached cautiously, this study explores a novel application of TRT in a specific patient population under active surveillance.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 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 this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ahmed Aly — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.