NCT06123156 Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
| NCT ID | NCT06123156 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Rouen |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2030-02 |
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 188 participants in total. It began in 2025-09-25 with a primary completion date of 2030-02.
⚠ 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
This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.
Eligibility Criteria
Inclusion Criteria: * Men aged 18 to 70 * Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22). * Nerve-conserving surgery * Sexually active patient without treatment for erectile function prior to surgery * Presence of a regular sexual partner (male or female) * Adult having read and understood the information letter and signed the consent form * Membership of a social security scheme Exclusion Criteria: * T4 tumor or tumor requiring extended surgery * Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22. * History of prostate cancer * Sleep disorders, patients taking sedatives/hypnotics * Contraindication to SILDENAFIL EG 50 mg, film-coated tablet * Contraindication to placebo * Patients already treated with PDE5 inhibitors * Patients suffering from SARS COV 2\* * Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship. * Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent. * Person participating in another drug trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06123156 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying Rectal Cancer. 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 NCT06123156 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 188 participants.
Is NCT06123156 currently recruiting?
Yes, NCT06123156 is actively recruiting participants. Contact the research team at valerie.bridoux@chu-rouen.fr for enrollment information.
Where is the NCT06123156 trial being conducted?
This trial is being conducted at Amiens, France, Beauvais, France, Besançon, France, Bicêtre, France and 10 additional locations.
Who is sponsoring the NCT06123156 clinical trial?
NCT06123156 is sponsored by University Hospital, Rouen. The trial plans to enroll 188 participants.
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