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ID
Source
Brief title
Health condition
Prostate cancer; testosterone deficiency
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary endpoints include: urinary incontinence, hormonal functioning and BCR-free survival.
Background summary
Radical prostatectomy (RP) is currently the most common treatment for localized prostate cancer (PCa) in the Netherlands. Two common side effects of this procedure are urinary incontinence (5-27%) and erectile dysfunction (57-89%), both having a significant negative impact on quality of life. It is known that with age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). This does not necessarily lead to symptoms like decreased sexual desire, fatigue or erectile dysfunction. If men do have symptoms, the treatment of testosterone deficiency does improve energy levels and erectile function. Both RP and TD are well-established to have a significant negative impact on sexual performance and are likely to add up in TD patients following RP.
The aim of this study is to assess the efficacy of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for PCa.
Study objective
Testosterone Therapy in (a)symptomatic, testosterone deficient men after Radical Prostatectomy improves functional and oncological outcome compared to testosterone deficient men who do not receive TRT.
Study design
3, 12 and 24 months follow-up after RP.
Intervention
Testosterone gel vs. placebo gel
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9229 |
| Other | CMO Arnhem Nijmegen : 2020-6874 |