Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified January 2026 by University of Miami
Sponsor
University of Miami
Information Provided by (Responsible Party)
Thomas Masterson
Clinicaltrials.gov Identifier
NCT07278362
Other Study ID Numbers:
20250346
First Submitted
December 3, 2025
First Posted
December 11, 2025
Last Update Posted
February 22, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Prostate CancerHypogonadism, Male
Drug: Testosterone cypionate

Study Design

Study TypeInterventional
Actual Enrollment35 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleSafety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Study Start DateMay 30, 2026
Actual Primary Completion Date4yrs 11mos from now
Actual Study Completion Date5yrs 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Testosterone cypionate
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
Drug: Testosterone cypionate
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Outcome Measures

Primary Outcome Measures
  1. Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
    Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.
Secondary Outcome Measures
  1. Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months
    The mean change in serum PSA levels (ng/mL) will be measured at baseline and 12 months after initiation of TRT. PSA levels will be assessed using a standardized immunoassay. The mean change in PSA level will be used to evaluate clinical outcomes related to TRT.
  2. Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months
    The mean change in serum total testosterone (ng/dL) will be measured at baseline and 12 months after initiation of TRT. Total testosterone levels will be assessed using a standardized immunoassay. The mean change in total testosterone level will be used to evaluate clinical outcomes related to TRT.
  3. Mean Change in Hematocrit Levels (%) from Baseline to 12 Months
    The mean change in hematocrit levels (%) will be measured from baseline and 12 months after initiation of TRT. Hematocrit levels will be assessed using a standardized immunoassay. The mean change in hematocrit level will be used to evaluate clinical outcomes related to TRT.
  4. Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months
    The mean change in prostate volume (mL) will be measured at baseline and 12 months after initiation of TRT. Prostate volume will be calculated from T2-weighted mpMRI images using standardized volumetric analysis techniques. The mean change in volume will be used to evaluate clinical outcomes related to TRT.
  5. Mean Change in EPIC-26 Scores from Baseline to 12 Months
    Quality of life will be assessed using the EPIC-26 questionnaire at baseline and 12 months. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
  6. Mean Change in SF-12 Scores from Baseline to 12 Months
    Quality of life will be assessed using the SF-12 questionnaire at baseline and 12 months. The measure includes items assessing physical and mental functioning and yields two scores for these two components of quality of life. These final scores are norm-based, meaning a score of 50 represents the US population average, with a standard deviation of 10. Scores higher than 50 indicate better health status, while scores lower than 50 suggest worse health status The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
  7. Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months
    Quality of life will be assessed using the Aging Male's Symptoms Score (AMS) at baseline and 12 months. Scores range from 17 to 85, with higher scores indicating more severe symptoms. The mean change in scores will be used to evaluate symptom improvement associated with TRT.
  8. Progression-Free Survival (PFS) from Baseline to 5 Years
    Elapsed time from treatment initiation until disease progression, conversion to active treatment, or death from any cause. Median PFS, if attained, will also be reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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, and had a second confirmatory biopsy within the last 12 months
Males diagnosed with low-risk prostate cancer undergoing active surveillance
Two confirmatory testosterone levels \<300 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
Uncontrolled cardiovascular disease and sleep apnea
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of Miami
Locations
Desai Sethi Urology Institute | Miami Florida, United States, 33136Sylvester Comprehensive Cancer Center | Miami Florida, United States, 33136
Investigators
Principal Investigator: Thomas Masterson, MD, University of Miami