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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07278362
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2031
Completion
May 31, 2032

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Desai Sethi Urology InstituteMiamiFlorida33136
Thomas Masterson (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Thomas Masterson (PRINCIPAL_INVESTIGATOR)

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