OncoMatch/Clinical Trials/NCT04833426
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Is NCT04833426 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Testosterone gel for prostatic neoplasms.
Treatment: Testosterone gel — Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage CN0M0
Excluded: Stage PT3B, PT4
Non-metastatic disease (cN0M0) based on the use of nomograms or imaging; Pathological stage pT3b or pT4 in the RP specimen [excluded]; Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen [excluded]
Prior therapy
Must have received: radical prostatectomy — primary treatment
Radical prostatectomy performed as primary treatment
Must have received: nerve-sparing procedure — at least one-sided
At least one-sided nerve-sparing procedure performed
Cannot have received: anti-hormonal therapy
Exception: active surveillance allowed
Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
Cannot have received: radiotherapy
Exception: active surveillance allowed
Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
Cannot have received: brachytherapy
Exception: active surveillance allowed
Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
Cannot have received: testosterone therapy
Previous use of testosterone therapy for any reason
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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