RecruitingPhase 4NCT06733350

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


Sponsor

Roswell Park Cancer Institute

Enrollment

600 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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

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Interventions

PROCEDUREBiopsy of Prostate

Undergo prostate biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERPatient Observation

Undergo standard AS

OTHERQuestionnaire Administration

Ancillary studies

DRUGTherapeutic Testosterone

Given via injection, gel, lotion, or transdermal patch


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06733350


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