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.
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
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
Parallel
Biopsy of Prostate
Procedure/SurgeryUndergo prostate biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Patient Observation
Other interventionUndergo standard AS
Questionnaire Administration
Other interventionAncillary studies
Therapeutic Testosterone
DrugGiven via injection, gel, lotion, or transdermal patch
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.
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.
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.
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.
Radiographic progression
Will assess change in the size of abnormal magnetic resonance imaging (MRI) lesions, if any. Will utilize the PRECISE scoring system, which considers factors such as changes in lesion volume or appearance on MRI and can provide a standardized and objective method for assessing 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.
Biochemical progression
Will be assessed by change in the PSA over time. 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.
Incidence of testosterone replacement therapy (TRT)-related adverse events
Will be assessed in Group 2 patients. Will be summarized by attribution and grade using frequencies and relative frequencies.
Incidence of TRT-related complications
Will be assessed in Group 2 patients. Will be summarized by attribution and grade using frequencies and relative frequencies.
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