Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
Status
RECRUITING
Phase
PHASE4
Age
≥ 18 Years
Enrollments
600Conditions
Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8Drugs
Therapeutic TestosteroneSummary
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.
Detailed 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.
Locations
1 location Found with status Recruiting
Eligibility Criteria
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
* 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
Study Plan
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 ProstateDescription:
Undergo prostate biopsyPROCEDURE:
Biospecimen CollectionDescription:
Undergo blood sample collectionPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIOTHER:
Patient ObservationDescription:
Undergo standard ASOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
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 ProstateDescription:
Undergo prostate biopsyPROCEDURE:
Biospecimen CollectionDescription:
Undergo blood sample collectionPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIOTHER:
Patient ObservationDescription:
Undergo standard ASOTHER:
Questionnaire AdministrationDescription:
Ancillary studiesDRUG:
Therapeutic TestosteroneDescription:
Given via injection, gel, lotion, or transdermal patch
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 ProstateDescription:
Undergo prostate biopsyPROCEDURE:
Biospecimen CollectionDescription:
Undergo blood sample collectionPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIOTHER:
Patient ObservationDescription:
Undergo standard ASOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Outcome Measures
Primary Outcome Measures
Gleason grade progression
Discontinuation of active surveillance
International Prostate Symptom Score (Quality-of-life)
Sexual Health Inventory for Men score (Quality-of-life)
Secondary Outcome Measures
Radiographic progression
Biochemical progression
Incidence of testosterone replacement therapy (TRT)-related adverse events
Incidence of TRT-related complications
TRT discontinuation
Timeline
Last Updated
February 4, 2025Start Date
December 13, 2024Today
May 12, 2025Completion Date ( Estimated )
January 15, 2029
Sponsors of this trial
Lead Sponsor
Roswell Park Cancer Institute
RECRUITING 
≥ 18 Years