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Clinical trial Recruiting at 11 sites Interventional Ages 18 and up Men only

Comparing brachytherapy and SBRT for erectile dysfunction in prostate cancer

Official title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

Run by Center Eugene Marquis · NCT03830788 · Data updated 2026-11-12

This study is testing whether brachytherapy or SBRT is better at treating prostate cancer while also looking at how each treatment affects erectile dysfunction.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment240 (estimated)
SponsorCenter Eugene Marquis
Academic / other
Locations20 sites (Albi and 19 other locations)
StatusRecruiting
StartedOctober 4, 2019
Main results expectedApril 4, 2030
Study endsApril 4, 2031
Registry record updatedAugust 1, 2025
Trial IDNCT03830788 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with biopsy-proven low or intermediate risk prostate adenocarcinoma who are potent and eligible for curative treatment.

Probably not a fit

Patients undergoing androgen deprivation therapy or those with contraindications for brachytherapy or MRI will not benefit from this study.

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

What this trial studies

This study compares the effectiveness of brachytherapy and stereotactic body radiotherapy (SBRT) in treating low and intermediate risk prostate cancer, with a specific focus on the impact of these treatments on erectile dysfunction. A total of 240 patients will be randomized into two groups: one receiving SBRT and the other receiving brachytherapy. The primary goal is to conduct a cost-utility analysis over three years, measuring the cost per quality-adjusted life year (QALY) gained. Secondary objectives include evaluating the cost-effectiveness of both treatment methods.

Why it matters

Potential benefit: If successful, this study could provide insights into which treatment option minimizes erectile dysfunction while being cost-effective for patients with prostate cancer.

How similar studies have gone: Previous studies have shown varying success with similar approaches, but this specific comparison of SBRT and brachytherapy in this context is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Main inclusion criteria

* Biopsy proven prostate adenocarcinoma,
* Low risk prostate cancer according to d'Amico (T1-T2a and PSA \<10 ng/ml, and Gleason score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor with Gleason score 7 (4 + 3),
* Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting,

Main exclusion criteria

* Androgen deprivation therapy,
* Contraindication for prostate Iodine 125 brachytherapy (Prostate volume \> 50 cc, impossibility if general anesthesia).
* Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)
* Participation to another research which could have an impact on the study treatment and the outcomes

Where it's running

  • ICO Paul Papin
    Angers, France     Recruiting
  • Polyclinique Bordeaux-Aquitaine
    Bordeaux, France     Recruiting
  • CLCC Georges-François Leclerc
    Dijon, France     Recruiting
  • Centre Amethys - Charlebourg - La Défense
    La Garenne-Colombes, France     Recruiting
  • Institut Curie
    Paris, France     Recruiting
  • Centre Eugene Marquis
    Rennes, France     Recruiting
Show 14 more locations
  • Centre d'oncologie et de radiothérapie Saint Jean
    Saint-Doulchard, France     Recruiting
  • Institut de Cancérologie de l'Ouest - Site Gauducheau
    Saint-Herblain, France     Recruiting
  • CHU Tours - Hôpital Bretonneau
    Tours, France     Recruiting
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, France     Recruiting
  • Gustave Roussy
    Villejuif, France     Recruiting
  • Clinique Claude Bernard
    Albi, France     Not yet recruiting
  • Institut Bergonié
    Bordeaux, France     Not yet recruiting
  • Centre de Cobalthérapie Hartman
    Levallois-Perret, France     Not yet recruiting
  • CH Lyon Sud
    Lyon, France     Terminated
  • Institut régional du Cancer de Montpellier
    Montpellier, France     Not yet recruiting
  • Hôpital Lyon Sud
    Pierre-Bénite, France     Terminated
  • Institut Jean Godinot
    Reims, France     Not yet recruiting
  • Institut de Cancérologie Lucien Neuwirth
    Saint-Priest-en-Jarez, France     Not yet recruiting
  • Institut Claudius Régaud
    Toulouse, France     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
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Prostate Cancer 1464Center Eugene Marquis 8
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.