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Can a daily pill preserve erections after rectal cancer therapy?

NCT ID NCT06123156

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether taking sildenafil (a drug for erectile dysfunction) daily for 10 months, starting 30 days after surgery, can prevent long-term erectile problems in men treated for rectal cancer with radiation and surgery. The trial includes 188 men aged 18 to 70 who had normal erectile function before treatment. The goal is to see if early rehabilitation helps maintain erectile function one year after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sildenafil (a drug for erectile dysfunction, taken daily as a 50 mg pill)
What this could lead to
If it works, this could offer a way to prevent long-term erectile dysfunction in men treated for rectal cancer, improving quality of life after recovery.
What could go wrong
This is a Phase 3 trial, but it only includes men with normal erectile function before treatment, so results may not apply to everyone. Sildenafil can cause side effects like headache or flushing, and the study is still recruiting, so outcomes are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm erectile dysfunction prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aphp Bicetre

    RECRUITING

    Bicêtre, 94275, France

  • Aphp Hegp

    RECRUITING

    Paris, 75908, France

  • Aphp St Antoine

    RECRUITING

    Paris, 75012, France

  • Chu Amiens

    RECRUITING

    Amiens, 80054, France

  • Chu Besancon

    RECRUITING

    Besançon, 25030, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • Chu Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Chu Lille

    RECRUITING

    Lille, 59000, France

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

  • Chu Tours

    RECRUITING

    Tours, 37000, France

  • Hopital Beauvais

    RECRUITING

    Beauvais, 60000, France

  • Institut Bordeaux Colorectal

    RECRUITING

    Bordeaux, 33000, France

  • Institut Du Cancer Montpellier

    RECRUITING

    Montpellier, 34000, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

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