Comparing brachytherapy and SBRT for erectile dysfunction in prostate cancer
Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy
NA · Center Eugene Marquis · NCT03830788
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Center Eugene Marquis (other) |
| Locations | 20 sites (Albi and 19 other locations) |
| Trial ID | NCT03830788 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-proven low or intermediate risk prostate adenocarcinoma who are potent and eligible for curative treatment.
Not a fit: Patients undergoing androgen deprivation therapy or those with contraindications for brachytherapy or MRI will not benefit from this study.
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 performed: Previous studies have shown varying success with similar approaches, but this specific comparison of SBRT and brachytherapy in this context is relatively novel.
Eligibility criteria
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 this trial is running
Albi and 19 other locations
- Clinique Claude Bernard — Albi, France (NOT_YET_RECRUITING)
- ICO Paul Papin — Angers, France (RECRUITING)
- Institut Bergonié — Bordeaux, France (NOT_YET_RECRUITING)
- Polyclinique Bordeaux-Aquitaine — Bordeaux, France (RECRUITING)
- CLCC Georges-François Leclerc — Dijon, France (RECRUITING)
- Centre Amethys - Charlebourg - La Défense — La Garenne-Colombes, France (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)
- Institut Curie — Paris, France (RECRUITING)
- Hôpital Lyon Sud — Pierre-Bénite, France (TERMINATED)
- Institut Jean Godinot — Reims, France (NOT_YET_RECRUITING)
- Centre Eugene Marquis — Rennes, France (RECRUITING)
- Centre d'oncologie et de radiothérapie Saint Jean — Saint-Doulchard, France (RECRUITING)
- Institut de Cancérologie de l'Ouest - Site Gauducheau — Saint-Herblain, France (RECRUITING)
- Institut de Cancérologie Lucien Neuwirth — Saint-Priest-en-Jarez, France (NOT_YET_RECRUITING)
- Institut Claudius Régaud — Toulouse, France (NOT_YET_RECRUITING)
- CHU Tours - Hôpital Bretonneau — Tours, France (RECRUITING)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (RECRUITING)
- Gustave Roussy — Villejuif, France (RECRUITING)
Study contacts
- Principal investigator: Renaud De Crevoisier, PR — Centre Eugène Marquis
- Study coordinator: Martine Gestin, PhD
- Email: m.gestin@rennes.unicancer.fr
- Phone: +33(0)299253036
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.
Conditions: Prostate Cancer, SBRT, brachytherapy, localized low-risk and intermediate risk prostate cancer