Early sildenafil to prevent long-term erectile dysfunction after rectal cancer surgery and radiotherapy
Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé
This study will try giving sildenafil soon after radiotherapy and nerve-sparing rectal cancer surgery to see if it prevents long-term erectile dysfunction in sexually active men.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 14 sites (Amiens and 13 other locations) |
| Trial ID | NCT06123156 on ClinicalTrials.gov |
What this trial studies
This Phase 3 study compares sildenafil to placebo given after neoadjuvant radiotherapy and nerve-sparing total mesorectal excision in men with rectal cancer. Eligible participants have normal preoperative erectile function and will receive either sildenafil or placebo treatment postoperatively. Erectile function will be followed for 12 months, using standardized measures such as the IIEF erectile function domain. The trial is conducted at multiple French university hospitals to determine whether early pharmacologic rehabilitation reduces chronic erectile dysfunction after treatment.
Who should consider this trial
Good fit: Sexually active men aged 18–70 with normal preoperative erectile function who undergo neoadjuvant radiotherapy followed by nerve-sparing total mesorectal excision with colorectal or coloanal anastomosis are the intended participants.
Not a fit: Men with pre-existing erectile dysfunction, T4 or otherwise locally advanced tumors requiring extended surgery, non-nerve-sparing operations, or contraindications to sildenafil are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, early sildenafil could reduce the rate of long-term erectile dysfunction and improve sexual quality of life after rectal cancer treatment.
How similar studies have performed: PDE5 inhibitors like sildenafil have been studied after prostatectomy with mixed results, and their specific use after combined radiotherapy and proctectomy for rectal cancer is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens and 13 other locations
- Chu Amiens — Amiens, France (Recruiting)
- Hopital Beauvais — Beauvais, France (Recruiting)
- Chu Besancon — Besançon, France (Recruiting)
- Aphp Bicetre — Bicêtre, France (Recruiting)
- Chu Bordeaux — Bordeaux, France (Recruiting)
- Institut Bordeaux Colorectal — Bordeaux, France (Recruiting)
- Chu Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Chu Lille — Lille, France (Recruiting)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
- Institut Du Cancer Montpellier — Montpellier, France (Recruiting)
- Aphp St Antoine — Paris, France (Recruiting)
- Aphp Hegp — Paris, France (Recruiting)
- Chu Rouen — Rouen, France (Recruiting)
- Chu Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Valérie Bridoux
- Email: valerie.bridoux@chu-rouen.fr
- Phone: 0232881347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.