Prostatic Neoplasms Clinical Trial
— ENFORCEOfficial title:
Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
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).
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Unmeasurable PSA after RP 2. pT2-pT3a after RP 3. ISUP 1-3 regardless of surgical margins 4. ISUP 4-5 with negative surgical margins 5. At least one-sided nerve-sparing procedure 6. Baseline score sexual functioning domain of = 40 points (EPIC-26) Exclusion Criteria: 1. Metastatic disease (cN1/M1) 2. pT3b or pT4 after RP 3. Prior treatment for PCa 4. Prior TRT 5. Medical history of male breast- or liver carcinoma 6. Uncontrolled hypertension 7. General contra-indication for TRT 8. Allergy for components in TRT 9. Use of vitamin K-antagonists 10. BMI > 30 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Jeroen Bosch Hospital | 's-Hertogenbosch | |
Netherlands | Netherlands Cancer Institute | Amsterdam | |
Netherlands | Catharina Hospital | Eindhoven | |
Netherlands | Zuyderland | Heerlen | |
Netherlands | St. Antonius Hospital | Nieuwegein | |
Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
Netherlands | Radboud university medical center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Canisius-Wilhelmina Hospital | Besins Healthcare |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically relevant (=12 points) difference in the EPIC-26 sexual functioning domain score, 12 months after radical prostatectomy between groups. | Functional recovery after radical prostatectomy will be assessed by EPIC-26 questionnaire, a Patient Reported Outcome Measure (PROM). Patients will be asked to complete this questionnaire online. | 12 months | |
Secondary | Clinically relevant (=12 points) difference in the EPIC-26 sexual functioning domain score 3 months after radical prostatectomy between groups. | Clinical relevance (>12 points) for sexual function domain score as measured by EPIC-26. | 3 months | |
Secondary | Clinically relevant (=12 points) difference in the EPIC-26 sexual functioning domain score 24 months after radical prostatectomy between groups. | Clinical relevance (>12 points) for sexual function domain score as measured by EPIC-26. | 24 months | |
Secondary | Clinically relevant (=9 points) difference in the EPIC-26 urinary incontinence domain score, 12 months after radical prostatectomy between groups. | Clinical relevance (>9 points) for Urinary incontinence domain score as measured by EPIC-26. | 12 months | |
Secondary | Clinically relevant (=9 points) difference in the EPIC-26 urinary incontinence domain score, 24 months after radical prostatectomy between groups. | Clinical relevance (>9 points) for Urinary incontinence domain score as measured by EPIC-26. | 24 months | |
Secondary | Clinically relevant (=6 points) difference in the EPIC-26 for hormonal functioning domain score, 12 months after radical prostatectomy between groups. | Clinical relevance (>6 points) for hormonal functioning domain score as measured by EPIC-26. | 12 months | |
Secondary | Clinically relevant (=6 points) difference in the EPIC-26 for hormonal functioning domain score, 24 months after radical prostatectomy between groups. | Clinical relevance (>6 points) for hormonal functioning domain score as measured by EPIC-26. | 24 months | |
Secondary | Difference in biochemical recurrence rate between groups. | Biochemical recurrence (BCR) is defined as the occurrence of measurable (>0.1 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the placebo and control group will be compared to determine the influence of testosterone therapy on BCR. | 5 years |
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