RecruitingPhase 3NCT04833426

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy


Sponsor

Canisius-Wilhelmina Hospital

Enrollment

140 participants

Start Date

Dec 12, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether testosterone levels before and after surgery to remove the prostate (radical prostatectomy) affect cancer outcomes and sexual function recovery. Testosterone deficiency is common in men with prostate cancer, and researchers want to know if it impacts how well surgery works and how quickly men recover. **You may be eligible if...** - You are a male 18 years or older - You have been diagnosed with prostate cancer, confirmed by biopsy - You are having radical prostatectomy as your primary treatment - At least one nerve bundle beside the prostate is being spared during surgery - Your cancer has not spread (confirmed by imaging) - Your PSA (prostate-specific antigen) is undetectable after surgery - You have testosterone deficiency (confirmed by blood tests on two separate occasions) - You had some sexual function before surgery **You may NOT be eligible if...** - Your prostate cancer has spread to other organs - Your PSA was detectable after surgery - You have no testosterone deficiency - You had prior prostate treatment before this surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone gel

Topical gel containing testosterone

DRUGPlacebo

Topical gel without active substance


Locations(10)

Amsterdam UMC location VUmc

Amsterdam, Netherlands

Netherlands Cancer Institute

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Catharina Hospital

Eindhoven, Netherlands

Treant

Emmen, Netherlands

Zuyderland

Heerlen, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Radboud university medical center

Nijmegen, Netherlands

Máxima Medical Centre

Veldhoven, Netherlands

View Full Details on ClinicalTrials.gov

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NCT04833426


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