Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Prostate Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Prostate cancer is the most common cancer in humans, but low mortality, around 10 / 100,000 patients / year. It differs from other cancers by its high rate of cure, as well as a long term survival. Nu...
Detailed Description
Prostate cancer is the most common cancer in humans with an incidence of about 100 / 100,000 cases / year in Europe, but low mortality, around 10 / 100,000 patients / year. It differs from other cance...
Eligibility Criteria
Inclusion
- 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 on or two 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
- 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
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2027
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04105920
Start Date
October 5 2021
End Date
April 5 2027
Last Update
June 24 2025
Active Locations (3)
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1
Centre Jean François Leclerc
Dijon, France, 21079
2
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, France, 38043
3
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495