NCT04833426 Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
| NCT ID | NCT04833426 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Canisius-Wilhelmina Hospital |
| Condition | Prostatic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2022-12-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).
Eligibility Criteria
Inclusion criteria 1. Men aged 18 years or older 2. Histologically confirmed prostate cancer 3. Radical prostatectomy performed as primary treatment 4. At least one-sided nerve-sparing procedure performed 5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging 6. Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP 7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain 8. Testosterone deficiency, defined as total testosterone \<8 nmol/L, or total testosterone between 8-12 nmol/L with free testosterone \<225 pmol/L, measured on two separate occasions, with normal or elevated luteinising hormone (LH) Exclusion criteria 1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed) 2. Previous use of testosterone therapy for any reason 3. Pathological stage pT3b or pT4 in the RP specimen 4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen 5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed 6. History of male breast cancer or liver tumour 7. Uncontrolled hypertension 8. General contraindications for TRT 9. Allergy for components in TRT agent or placebo 10. Use of vitamin K antagonists 11. Body mass index (BMI) \>30 kg/m²
Contact & Investigator
Diederik Somford, MD, PhD
PRINCIPAL INVESTIGATOR
Canisius-Wilhelmina Hospital
Frequently Asked Questions
Who can join the NCT04833426 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04833426 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT04833426 currently recruiting?
Yes, NCT04833426 is actively recruiting participants. Contact the research team at enforce@cwz.nl for enrollment information.
Where is the NCT04833426 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amsterdam, Netherlands, Arnhem, Netherlands, Eindhoven, Netherlands and 6 additional locations.
Who is sponsoring the NCT04833426 clinical trial?
NCT04833426 is sponsored by Canisius-Wilhelmina Hospital. The principal investigator is Diederik Somford, MD, PhD at Canisius-Wilhelmina Hospital. The trial plans to enroll 140 participants.