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

University of Miami

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypogonadism, Male; Prostate Cancer

Treatments: Drug: Testosterone cypionate

Study type: Interventional

Funder types: Other

Identifiers

NCT07278362

20250346

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Testosterone cypionate

Experimental group

Description:

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

Treatment:

Drug: Testosterone cypionate