Impact of testosterone on sexual functioning, urinary continence and oncological outcome following radical prostatectomy

Phase 1

• Conditions: ate-onset hypogonadism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-003012-27-NL
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-04
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 750

Inclusion Criteria

Prescreening eligibility criteria
1. Signed informed consent form 1 (IC)
2. Age > 18 years
3. Histologically confirmed prostate cancer
4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
5. Non-metastatic disease (cN0M0)
6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
7. Willing to undergo testosterontherapy/placebo by intramuscular injection
8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.

Inclusioncriteria:
8.Signed informed consent form 2 (IC)
9.Undetectable PSA level at 4-week follow-up
10. pT2-pT3a on specimen after RP
11. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.
12. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.
13. No general contra-indications for testosterone therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

Prescreening 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 testosterontherapy 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. metastases (cN1/M1)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified