RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-15
Study Completion:2029-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06733350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men aged ≥ 18 years
  2. * Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \[NCCN\] very low, low, and intermediate favorable risk group)
  3. * 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
  1. * Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer
  2. * Patients with contraindications to TRT, which include,
  3. * Locally advanced or metastatic prostate cancer
  4. * Male breast cancer
  5. * Men with an active desire to have children
  6. * Hematocrit levels \> 54% or baseline hematocrit of 48-50%
  7. * Uncontrolled or poorly controlled congestive heart failure
  8. * IPSS score \> 19
  9. * Family history of venous thromboembolism
  10. * Unwilling or unable to follow protocol requirements
  11. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study

Contacts and Locations

Principal Investigator

Ahmed Aly
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Ahmed Aly, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2029-01-15

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2029-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Localized Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8