Testosterone therapy in men with low-risk 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 is a phase 4 interventional trial to assess the safety of testosterone cypionate in men who have low-risk prostate cancer and low testosterone, while on active surveillance. Eligible participants must have two low testosterone tests, mild symptoms, and be able to obtain TRT through insurance or out-of-pocket. The study is conducted at two Miami sites and is led by the University of Miami. Participants will receive testosterone cypionate and will be monitored for safety outcomes related to both hypogonadism and prostate cancer status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males aged ≥ 18 years old
* Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI
* Males diagnosed with low-risk prostate cancer on active surveillance
* Two confirmatory testosterone levels \<350 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
* Symptoms of low testosterone (Aging Male's Symptoms Score \>27)
* Able to obtain Testosterone medication through insurance or out-of-pocket
* Willing and able to provide written informed consent and able to comply with study requirements

Exclusion Criteria:

* Males \<18 years old
* History of Testosterone Replacement Therapy (TRT) within the past year.
* Current use of TRT
* Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
* PSA \>10 ng/mL at baseline
* Hematocrit \> 51% at baseline
* T3 or T4 disease
* Unstable angina
* History of breast cancer
* Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation
* Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket
* Unable or unwilling to provide informed consent or comply with study requirements

Where it's running

• Desai Sethi Urology Institute
  Miami, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Bruce Kava, MD — University of Miami
• Study coordinator: Bruce Kava, MD
• Email: bkava@med.miami.edu
• Phone: 305-243-6590

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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.