Testosterone Replacement Therapy for Prostate Cancer

Not yet recruiting at 1 trial location

Overseen By Laura Angulo Llanos

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: University of Miami

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.

Who Is on the Research Team?

Thomas Masterson, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for men with low-risk prostate cancer who are being closely monitored (active surveillance) and also have hypogonadism, a condition where the body doesn't produce enough testosterone. Specific eligibility details aren't provided.

Inclusion Criteria

Willing and able to provide written informed consent and able to comply with study requirements

I am a man aged 18 or older.

I was recently diagnosed with low-risk prostate cancer confirmed by two biopsies.

Exclusion Criteria

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 provide informed consent or comply with study requirements

I cannot or do not want to get Testosterone through insurance or by paying myself.

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone cypionate

Trial Overview The study is testing the safety of giving testosterone cypionate, a hormone replacement therapy, to men with low-risk prostate cancer and hypogonadism to see if it's safe and doesn't worsen their cancer.

How Is the Trial Designed?

Group I: Testosterone cypionate Experimental Treatment 1 Intervention

Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+