Testosterone Replacement for Low Testosterone in Prostate Cancer on Active Surveillance
This study is looking at how testosterone replacement therapy (TRT) affects men with localized prostate cancer (cancer that hasn't spread) who are on active surveillance (AS). AS means closely watching the cancer without immediate treatment. The study is for men who have low testosterone (hypogonadal men), which can cause symptoms like low sex drive. Researchers want to see if TRT impacts how the cancer changes over time (Gleason grade progression) and if it affects when men might need to stop AS. They will also look at how TRT affects your quality of life, including urinary symptoms and sexual health. About 600 men will participate in this study.
- Study design
- This interventional study plans to enroll 600 men. Participants will be assigned to one of three groups, with one group receiving standard active surveillance.
- What's involved
- You may undergo a prostate biopsy, blood sample collection, MRI scans, and complete questionnaires. Your participation could last up to 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 5 years to assess various outcomes.
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Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ahmed Aly · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Gleason grade progressionFrom 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
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 surveillanceFrom start of active surveillance until discontinuation of active surveillance due to any cause or last follow-up, assessed up to 5 years
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)Up to 5 years
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)Up to 5 years
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.