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

• Conditions: Prostate cancer; testosterone deficiency

• Registration Number: NL-OMON25840
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary endpoints include: urinary incontinence, hormonal functioning and BCR-free survival.