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

NCT06733350 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: I-3920923NCI-2024-09551
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Gleason grade progression

  The Gleason grade progression will be summarized by group using standard Kaplan-Meier methods, where estimates of the median or specified rates will be obtained. Comparisons will be made between groups using the log-rank test. As exploratory analyses, Cox regression models may be considered to adjust for relevant demographic or clinical confounders. The Bonferroni method will be used to control the family-wise error rate at 0.10.

  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

  The discontinuation of active surveillance will be summarized by group using standard Kaplan-Meier methods, where estimates of the median or specified rates will be obtained. Comparisons will be made between groups using the log-rank test. As exploratory analyses, Cox regression models may be considered to adjust for relevant demographic or clinical confounders. The Bonferroni method will be used to control the family-wise error rate at 0.10.

  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)

  Will be modeled as a function of group, timepoint, their two-way interaction, and a random subject effect using linear mixed models. Tests about the appropriate contrasts of model estimates will be used to compare mean changes in quality of life between groups at specified timepoints. All model assumptions will be verified graphically, and transformations applied as appropriate. As exploratory analyses, additional models may be considered to adjust for relevant demographic or clinical confounders. The Bonferroni method will be used to control the family-wise error rate at 0.10.

  Up to 5 years

• Sexual Health Inventory for Men score (Quality-of-life)

  Will be modeled as a function of group, timepoint, their two-way interaction, and a random subject effect using linear mixed models. Tests about the appropriate contrasts of model estimates will be used to compare mean changes in quality of life between groups at specified timepoints. All model assumptions will be verified graphically, and transformations applied as appropriate. As exploratory analyses, additional models may be considered to adjust for relevant demographic or clinical confounders. The Bonferroni method will be used to control the family-wise error rate at 0.10.

  Up to 5 years

Secondary Outcomes (5)

• Radiographic progression

  From start of active surveillance until radiographic progression, definitive treatment, or last follow-up, assessed up to 5 years

• Biochemical progression

  From the start of active surveillance until prostate specific antigen (PSA) progression, definitive treatment, or last follow-up, assessed up to 5 years

• Incidence of testosterone replacement therapy (TRT)-related adverse events

  Up to 5 years

• Incidence of TRT-related complications

  Up to 5 years

• TRT discontinuation

  Up to 5 years

Study Arms (3)

Group 1 (AS)

ACTIVE COMPARATOR

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.

Procedure: Biopsy of Prostate; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Patient Observation; Other: Questionnaire Administration

Group 2 (TRT, AS)

EXPERIMENTAL

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.

Procedure: Biopsy of Prostate; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Patient Observation; Other: Questionnaire Administration; Drug: Therapeutic Testosterone

Group 3 (AS)

ACTIVE COMPARATOR

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.

Procedure: Biopsy of Prostate; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Patient Observation; Other: Questionnaire Administration

Interventions

Biopsy of Prostate PROCEDURE

Undergo prostate biopsy

Also known as: Prostate Biopsy, Prostatic Biopsy

Group 1 (AS); Group 2 (TRT, AS); Group 3 (AS)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group 1 (AS); Group 2 (TRT, AS); Group 3 (AS)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Group 1 (AS); Group 2 (TRT, AS); Group 3 (AS)

Patient Observation OTHER

Undergo standard AS

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Group 1 (AS); Group 2 (TRT, AS); Group 3 (AS)

Questionnaire Administration OTHER

Ancillary studies

Group 1 (AS); Group 2 (TRT, AS); Group 3 (AS)

Therapeutic Testosterone DRUG

Given via injection, gel, lotion, or transdermal patch

Also known as: Mertestate, Testoderm, Testolin, Testosterone, Testostroval, Testostroval-PA, Testro AQ, Trans-Testosterone, Virosterone

Group 2 (TRT, AS)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy; Watchful Waiting; Observation; Testosterone Propionate; Testosterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ahmed Aly

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

US (1)