🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 4Ages 18 Years - anyMaleRoswell Park Cancer Institute
NCT06733350 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Biopsy of Prostate
  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Patient Observation
  • Questionnaire Administration
📍

Where

1 site
Roswell Park Cancer Institute
Buffalo, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy