Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCanisius-Wilhelmina Hospital
About this trial
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 criteria
Qualifiers
Men aged 18 years or older
Histologically confirmed prostate cancer
Radical prostatectomy performed as primary treatment
At least one-sided nerve-sparing procedure performed
Disqualifiers
Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
Previous use of testosterone therapy for any reason
Pathological stage pT3b or pT4 in the RP specimen
Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
Trial design
Treatments tested in this trial
- Testosterone gel
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Canisius-Wilhelmina Hospital
Lead sponsor
Besins Healthcare
Collaborator
Source ClinicalTrials.gov