Impact of peri-operative tEstosterone levels on oNcological and Functional Outcomes in RadiCal prostatEctomy (ENFORCE trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25840

Enrollment

140

Registered

2021-01-28

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Testosterone gel vs. placebo gel

Eligibility

Inclusion criteria

Inclusion criteria: 1. Unmeasurable PSA after Radical Prostatectomy (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

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 testosterone replacement therapy 8. Allergy for components in TRT-agent 9. Use of vitamin K-antagonists 10. BMI > 30

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is a clinically relevant (=12 points) difference in the EPIC-26 domain for sexual functioning 12 months after RP in favor of TD men receiving TRT compared with TD men receiving placebo.	—

Secondary

Measure	Time frame
Secondary endpoints include: urinary incontinence, hormonal functioning and BCR-free survival.	—

Contacts

Public ContactDiederik Baas

Canisius Wilhelmina Ziekenhuis

d.baas@cwz.nl024-3658832

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)