Recruiting

Testosterone Replacement Therapy

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06733350

Conditions

Localized Prostate Carcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy of Prostate

Biospecimen Collection

Magnetic Resonance Imaging

Patient Observation

Questionnaire Administration

Study Details

Brief 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.

Conditions

Localized Prostate Carcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Study ID

NCT06733350

Start date

Jan 15, 2025

Status verified date

May, 2026

Completion date

Jan 15, 2029

Anticipated

Primary completion date

Jan 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men aged ≥ 18 years
  • Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \[NCCN\] very low, low, and intermediate favorable risk group)
  • Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate 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 an unsuitable candidate to participate in the study

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1 (AS)

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.

experimental: Group 2 (TRT, AS)

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.

active comparator: Group 3 (AS)

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.

Interventions

Biopsy of Prostate

Undergo prostate biopsy

Biospecimen Collection

Undergo blood sample collection

Magnetic Resonance Imaging

Undergo MRI

Patient Observation

Undergo standard AS

Questionnaire Administration

Ancillary studies

Therapeutic Testosterone

Given via injection, gel, lotion, or transdermal patch

Primary outcome measure

  • Gleason grade progression [ Time Frame: From start of active surveillance until any progression in primary, secondary, or a combination of Gleason grades, definitive treatment, or last follow-up, assessed up to 5 years ]
  • Discontinuation of active surveillance [ Time Frame: From start of active surveillance until discontinuation of active surveillance due to any cause or last follow-up, assessed up to 5 years ]
  • International Prostate Symptom Score (Quality-of-life) [ Time Frame: Up to 5 years ]
  • Sexual Health Inventory for Men score (Quality-of-life) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Ahmed Aly

716-845-6844ahmed.aly@roswellpark.org

Principal Investigator:

Ahmed Aly

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-05-14.