RightFit
RecruitingPhase 4

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

Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: MRI scans, Blood draws, Biopsies, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To examine the influence of TRT on radiographic progression in hypogonadal men with localized prostate cancer on active surveillance, by assessing changes in the size of abnormal magnetic resonance imaging (MRI) lesions."
  • "GROUP 1: Patients with normal testosterone level undergo standard AS for up to 5 years in the absence of disease progression."
  • "Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study."
  • "GROUP 2: Patients with low testosterone level associated with hypogonadal symptoms and willing to receive TRT receive testosterone per treating physician discretion via injection, gel, lotion, or transdermal patch and undergo standard AS for up to 5 years in the absence of disease progression or unacceptable toxicity."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests testosterone replacement therapy in men with low testosterone and prostate cancer that has not spread. These men are on active surveillance, which means regular checkups and tests without cancer treatment unless results change. The study looks at how this therapy affects cancer outcomes and quality of life.

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 or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older.
  • Have prostate cancer that has not spread and is suitable for active surveillance: very low risk, low risk, or favorable intermediate risk.
  • Understand that this is a research study and sign a consent form before any study procedures.

Who can't join

  • Have unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer.
  • For the testosterone therapy group: have prostate cancer that has grown into nearby areas or spread, or have male breast cancer.
  • For the testosterone therapy group: currently want to have children.
  • For the testosterone therapy group: have a hematocrit above 54%, or 48–50% at the start. Hematocrit is the share of blood made up of red blood cells.
  • For the testosterone therapy group: have heart failure that is not well controlled, meaning the heart does not pump blood well.
  • For the testosterone therapy group: have a urine symptom score (IPSS) above 19, or a family history of blood clots in veins.
  • Are unwilling or unable to follow study rules.
  • Have any condition that the study doctor thinks makes you unsuitable for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 * 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

Study sites (1)

NY