The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Participants will self-inject 100mg of testosterone cypionate once per week for 12 months
Desai Sethi Urology Institute
Miami, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT
Disease progression is defined as either (1) an increase in prostate cancer grade group on biopsy or (2) conversion from active surveillance to active treatment (e.g., surgery, radiation, or systemic therapy). The proportion of participants who meet either criterion within 12 months of initiating testosterone replacement therapy (TRT) will be reported.
Time frame: 12 months
Mean Change in Serum PSA Levels (ng/mL) from Baseline to 12 Months
The mean change in serum PSA levels (ng/mL) will be measured at baseline and 12 months after initiation of TRT. PSA levels will be assessed using a standardized immunoassay. The mean change in PSA level will be used to evaluate clinical outcomes related to TRT.
Time frame: Baseline, 12 Months
Change in Total Testosterone Levels (ng/dL) from Baseline to 12 Months
The mean change in serum total testosterone (ng/dL) will be measured at baseline and 12 months after initiation of TRT. Total testosterone levels will be assessed using a standardized immunoassay. The mean change in total testosterone level will be used to evaluate clinical outcomes related to TRT.
Time frame: Baseline, 12 Months
Mean Change in Hematocrit Levels (%) from Baseline to 12 Months
The mean change in hematocrit levels (%) will be measured from baseline and 12 months after initiation of TRT. Hematocrit levels will be assessed using a standardized immunoassay. The mean change in hematocrit level will be used to evaluate clinical outcomes related to TRT.
Time frame: Baseline, 12 Months
Mean Change in Prostate Volume (mL) as measured by mpMRI from Baseline to 12 Months
The mean change in prostate volume (mL) will be measured at baseline and 12 months after initiation of TRT. Prostate volume will be calculated from T2-weighted mpMRI images using standardized volumetric analysis techniques. The mean change in volume will be used to evaluate clinical outcomes related to TRT.
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Time frame: Baseline, 12 Months
Mean Change in EPIC-26 Scores from Baseline to 12 Months
Quality of life will be assessed using the EPIC-26 questionnaire at baseline and 12 months. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
Time frame: Baseline, 12 Months
Mean Change in SF-12 Scores from Baseline to 12 Months
Quality of life will be assessed using the SF-12 questionnaire at baseline and 12 months. The measure includes items assessing physical and mental functioning and yields two scores for these two components of quality of life. These final scores are norm-based, meaning a score of 50 represents the US population average, with a standard deviation of 10. Scores higher than 50 indicate better health status, while scores lower than 50 suggest worse health status The mean change in scores will be used to evaluate patient-reported outcomes related to TRT.
Time frame: Baseline, 12 Months
Mean Change in Aging Male's Symptoms Score (AMS) from Baseline to 12 Months
Quality of life will be assessed using the Aging Male's Symptoms Score (AMS) at baseline and 12 months. Scores range from 17 to 85, with higher scores indicating more severe symptoms. The mean change in scores will be used to evaluate symptom improvement associated with TRT.
Time frame: Baseline, 12 Months
Progression-Free Survival (PFS) from Baseline to 5 Years
Elapsed time from treatment initiation until disease progression, conversion to active treatment, or death from any cause. Median PFS, if attained, will also be reported.
Time frame: Baseline to 5 Years