Early sildenafil to prevent long-term erectile dysfunction after rectal cancer surgery and radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Valérie Bridoux
• Email: valerie.bridoux@chu-rouen.fr
• Phone: 0232881347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.