Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance

Last updated: May 13, 2026
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer

Treatment

Biopsy of Prostate

Biospecimen Collection

Patient Observation

Clinical Study ID

NCT06733350
I-3920923
I-3920923
NCI-2024-09551
  • Ages > 18
  • Male

Study Summary

This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men aged ≥ 18 years

  • Men with localized prostate cancer are eligible for active surveillance (NationalComprehensive Cancer Network [NCCN] very low, low, and intermediate favorable riskgroup)

  • Participant must understand the investigational nature of this study and sign anindependent ethics committee/institutional review board approved written informedconsent form prior to receiving any study related procedure

Exclusion

Exclusion Criteria:

  • Patients with NCCN intermediate unfavorable, high risk, or very high-risk localizedprostate cancer

  • For men being considered for Group 2 (TRT), Patients with contraindications to TRT,which include,

  • Locally advanced or metastatic prostate cancer

  • Male breast cancer

  • Men with an active desire to have children

  • Hematocrit levels > 54% or baseline hematocrit of 48-50%

  • Uncontrolled or poorly controlled congestive heart failure

  • IPSS (International Prostate Symptom Score) score > 19

  • Family history of venous thromboembolism

  • Unwilling or unable to follow protocol requirements

  • Any condition which in the investigator's opinion deems the participant anunsuitable candidate to participate in the study

Study Design

Total Participants: 600
Treatment Group(s): 6
Primary Treatment: Biopsy of Prostate
Phase: 4
Study Start date:
January 15, 2025
Estimated Completion Date:
January 15, 2029

Study Description

PRIMARY OBJECTIVES:

I. To investigate the impact of TRT on Gleason grade progression in hypogonadal men with localized prostate cancer on active surveillance, and the association between TRT and the likelihood of discontinuation of active surveillance in the same population.

II. To assess the impact of TRT on the quality of life, including changes in the International Prostate Symptom Score (IPSS) and the association with sexual health measured by the Sexual Health Inventory for Men (SHIM), in hypogonadal men with localized prostate cancer on active surveillance.

SECONDARY OBJECTIVES:

I. To examine the influence of TRT on radiographic progression in hypogonadal men with localized prostate cancer on active surveillance, by assessing changes in the size of abnormal magnetic resonance imaging (MRI) lesions.

II. To evaluate the association between TRT and biochemical progression by analyzing changes in prostate-specific antigen (PSA) levels over time in the studied population.

III. To systematically monitor and document TRT-related adverse events and complications, and concurrently assess the association between TRT and the likelihood of discontinuation due to adverse events in the studied population.

OUTLINE: Patients are assigned to 1 of 3 groups.

GROUP 1: Patients with normal testosterone level undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

GROUP 2: Patients with low testosterone level associated with hypogonadal symptoms and willing to receive TRT receive testosterone per treating physician discretion via injection, gel, lotion, or transdermal patch and undergo standard AS for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

GROUP 3: Patients with low testosterone level with no symptoms, or low testosterone level associated with hypogonadal symptoms but declined TRT undergo standard AS for up to 5 years in the absence of disease progression. Patients undergo blood sample collection and MRI throughout the trial and may undergo prostate biopsy on study.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

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