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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Hypogonadism, Male
• Intervention / Treatment: Drug: Testosterone cypionate

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thomas Masterson, MD; Phone Number: 305-243-6260; Email: TMasterson@med.miami.edu
• Study Contact Backup: Name: Laura Angulo Llanos; Phone Number: 305-243-4850; Email: lxa2084@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
      • Principal Investigator: Thomas Masterson
    • Miami, Florida, United States, 33136
      • Desai Sethi Urology Institute
      • Principal Investigator: Thomas Masterson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline, 12 Months
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.	Baseline to 5 Years

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Thomas Masterson, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2032

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Gonadal Disorders; Hypogonadism; Prostatic Neoplasms; Eunuchism; testosterone 17 beta-cypionate
• Other Study ID Numbers: 20250346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No