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

NCT07278362 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20250346
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer; Hypogonadism, Male

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (8)

• Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months

  Baseline, 12 Months

• Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months

  Baseline, 12 Months

• Mean Change in Hematocrit Levels (%) from Baseline to 12 Months

  Baseline, 12 Months

• Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months

  Baseline, 12 Months

• Mean Change in EPIC-26 Scores from Baseline to 12 Months

  Baseline, 12 Months

Study Arms (1)

Testosterone cypionate

EXPERIMENTAL

Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Drug: Testosterone cypionate

Interventions

Testosterone cypionate DRUG

Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Testosterone cypionate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Desai Sethi Urology Institute

Miami, Florida, 33136, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Eunuchism

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Thomas Masterson, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Masterson, MD

CONTACT

305-243-6260; TMasterson@med.miami.edu

Laura Angulo Llanos

CONTACT

305-243-4850; lxa2084@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2032
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)