Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
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- STATUS
- Recruiting
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- End date
- Jan 1, 2024
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- participants needed
- 142
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- sponsor
- Dana-Farber Cancer Institute
Summary
The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.
Description
The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score < 7 (3+4), who have undetectable PSA (<0.1 ng/mL using a sensitive PSA assay) for > 2 years after radical prostatectomy, and who have androgen deficiency.
Details
| Condition | Prostate Cancer |
|---|---|
| Treatment | Placebo, Testosterone Cypionate 100 MG/ML |
| Clinical Study Identifier | NCT03716739 |
| Sponsor | Dana-Farber Cancer Institute |
| Last Modified on | 9 February 2022 |
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