Using hyaluronic acid to help maintain sexual function during prostate cancer treatment
Phase III Trial Randomized to Evaluate the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies
This study is testing if hyaluronic acid can help men keep their sexual function during treatment for prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Dijon and 2 other locations) |
| Trial ID | NCT04105920 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hyaluronic acid in preserving sexual function in patients undergoing prostate brachytherapy for localized prostate cancer. The study focuses on patients with favorable-grade prostate adenocarcinoma and aims to assess the impact of hyaluronic acid on erectile function post-treatment. Participants will be monitored for changes in sexual function and overall quality of life following the intervention. The trial includes specific eligibility criteria to ensure that candidates are suitable for brachytherapy and can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 80 with localized prostate adenocarcinoma eligible for brachytherapy.
Not a fit: Patients with nodal or distant metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for prostate cancer patients by preserving erectile function after treatment.
How similar studies have performed: While the use of hyaluronic acid in this context is novel, previous studies have shown promising results in preserving erectile function with similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 to 80 years old. * Patients over 75 years old must have a G8 score ≥ 14 or oncogeriatric assessment.The geriatrician's expertise will validate the brachytherapy treatment. * Karnofsky performance status ≥ 60% (ECOG performance status 0-2) * Patients diagnosed with histologically proven localized prostate adenocarcinoma * Prostate cancer eligible for brachytherapy according to the following criteria: * at. Low risk prostate cancer: Gleason score \<7 and PSA \<10 ng / ml AND cT1-cT2a * Intermediate risk prostate cancers with a single adverse factor: Gleason score = 7 (3 + 4) OR PSA 10-15ng / ml OR cT2b-cT2c / ml * less than 50% positive biopsies * Volume of the prostate \<60 cc * No middle lobe * IPSS \<15/35 * Initial IIEF5 score, no treatment, greater than or equal to 20/25 * Patient able to sign an informed consent form * Patient benefiting from a social insurance system or similar system Exclusion Criteria: * Nodal or distant metastatic evolution * History of abdominal or pelvic irradiation * Anterior treatment for prostate cancer, including hormone therapy with LHRH analogue or GnRH antagonist. * History of prostate resection, not allowing brachytherapy seeds implantation. * Uncontrolled cancer (except basal cell skin cancer) * Current clinical study that may interfere with this study * Patient unable to complete a self-administered questionnaire and understand the ins and outs of the trial * Major patients protected by law * Allergy to hyaluronic acid
Where this trial is running
Dijon and 2 other locations
- Centre Jean François Leclerc — Dijon, France (Recruiting)
- Radiothérapie, Hôpital A. Michallon, CHU de Grenoble — Grenoble, France (Recruiting)
- Centre Hospitalier Lyon Sud — Pierre-Bénite cedex, France (Recruiting)
Study contacts
- Study coordinator: Samy HORN, Dr
- Email: samy.horn@chu-lyon.fr
- Phone: 04 78 86 42 63
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.