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Not yet recruiting NCT07278362

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

Phase IV Interventional Prostate Cancer Hypogonadism, Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Testosterone cypionate.
Who it may be relevant to
Registry conditions: Prostate Cancer, Hypogonadism, Male. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT [Time frame: 12 months]
Secondary outcome measures (8)
  • Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Mean Change in Hematocrit Levels (%) from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Mean Change in EPIC-26 Scores from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Mean Change in SF-12 Scores from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months [Time frame: Baseline, 12 Months]
  • Progression-Free Survival (PFS) from Baseline to 5 Years [Time frame: Baseline to 5 Years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Desai Sethi Urology Institute — Miami
  • Sylvester Comprehensive Cancer Center — Miami

Identifiers

NCT: NCT07278362 · 20250346

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗