Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
Recruiting
Phase 3
Interventional Study
Prostatic Neoplasms
Hypogonadism
Testosterone Deficiency
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Canisius-Wilhelmina Hospital · Other
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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 …
Trial Locations
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Eligibility Criteria
Inclusion criteria
1. Men aged 18 years or older
2. Histologically confirmed prostate cancer
3. Radical prostatectomy performed as primary treatment
4. At least one-sided nerve-sparing procedure performed
5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
6. Undetectable PSA…
Contacts