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

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canisius-Wilhelmina Hospital
• Collaborator: Besins Healthcare
• Treatments: Testosterone

Criteria

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