Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE)

Phase 3

Recruiting

• Conditions: Late-onset Hypogonadism; testosterone deficiency; 10014701; 10038597

• Registration Number: NL-OMON52940
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Signed informed consent form 1 (IC)
2. Age > 18 years
3. Histologically confirmed prostate cancer
4. Scheduled for RP as primary treatment with at least one-side nervesparing.
5. Non-metastatic disease (cN0M0)
6. Willing to provide blood samples to determine testosterone level
7. Signed informed consent form 2 (ICF)
8. Undetectable PSA level at 4-week follow-up
9. Willing to use testosterone gel or placebo gel
10. a minimal score of 40 points for the EPIC-26 sexual domain.

Exclusion Criteria

1. Any previous treatment for prostate cancer, for example but not limited to:
anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is
allowed).
2. Previous use of TRT for any reason
3. History of male breast cancer
4. History of liver tumor
5. Uncontrolled hypertension
6. Allergy for components in the testosterone therapy agent or placebo
7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)
8. pT3b or pT4
9. Positive surgical margin (PSM) and ISUP 4 or 5 (ISUP 1 to 3 with PSM and
ISUP 4 or 5 without PSM can be included).
10. Metastatic lymph nodes if a PLND has been done
11. BMI > 30

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint for this study is the total sexual domain score coming from<br /><br>the EPIC-26 questionnaire, 12 months after RP. Calculation of this domain score<br /><br>is done by calculating the average of the Standardized Values for items 57-60,<br /><br>64 and 68 (with 5 non-missing items needed to compute score). Corresponding<br /><br>with questions 8a, 8b, 9, 10, 11 and 12. This results in a number between 0 and<br /><br>100. A change of 12 points in this domain is considered clinically relevant. </p><br>