Evaluation of the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies

NCT04105920 | Active Not Recruiting

• 1 other identifier: 69HCL19_0298
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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. Numerous treatment techniques are available and of comparable effectiveness: as a result it must be given importance to the short and long term side effects of these different treatments. Prostate brachytherapy with permanent implants is thus one of the standard techniques for the treatment of localized prostate cancers of favorable grades (WHO grade 1-2). In comparison with prostatectomy and RTE, brachytherapy allows low rates of long-term urinary toxicities, and comparable rates of erectile function preservation. With regard to erectile dysfunction, their pathophysiology after irradiation is complex and poorly understood, including damage to the erector apparatus, innervation, vascularization, and of course the level of libido. As an example, the radiotherapy team of the Lyon Sud hospital showed that the delivering a the lowest dose of radiation to the pudendal arteries and to the penile bulb during RTE, leads to erectile preservation rates comparable with those from the literature with nearly 85% of patients with erectile function retained at 2 years . They were also able to retrospectively show that a lower dose to the pudendal arteries correlated with better erectile function during brachytherapy. The brachytherapy procedure requires general anesthesia and endorectal ultrasound, which are optimal conditions for injecting hyaluronic acid between the prostate, rectum, and pudendal arteries. This gesture has shown to induce very few morbidity. They want to demonstrate that the injection of hyaluronic acid during prostate brachytherapy will reduce the radiation dose to the pudendal arteries and penile bulb, and thus improve the rate of preservation of erectile function in selected patients. This randomized phase III study comparing dyserection rates after CT performed with (Arm A) and without (Arm B) injection of HA, in a patient population without erectile dysfunction before treatment.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• interest of Hyalurocnic injection to protect pudendal arteries during prostate brachytherapy in the preservation of Erectile function at 2years.

  The primary endpoints is the comparison between the 2 groups of the proportion of patient with preserved erectile function. The erectile function will be assessed with the variation of IIEF-5 score between pre-treatment evaluation and 2years after treatment evaluation. Erectile function will be considered preserved in the absence of a decrease in the IIEF-5 score by more than 5 points.

  2 years

Secondary Outcomes (3)

• Evolution of erectile function.

  2 years

• The IPDE5 consumption at 2 years

  2 years

• Erection satisfaction at 2 years

  2 years

Other Outcomes (9)

• Psychosocial dimensions

  2 years

• Response assessment of IPDE5 (Phosphodiesterase 5 inhibitors ) treatement.

  6 months

• The incidence of acute gastrointestinal and gastrourinary toxicity

  6 months

Study Arms (2)

hyaluronic acid arm

EXPERIMENTAL

Patients included in this arm, will have, before insertion of brachytherapy seeds in the prostate, an injection of hyaluronic acid between the prostate, rectum, and pudendal arteries

Device: Hyaluronic acid arm

Conventional brachytherapy

ACTIVE COMPARATOR

Patients included in this arm will have the conventional brachytherapy.

Device: Hyaluronic acid arm

Interventions

Hyaluronic acid arm DEVICE

Patients included in this arm, will have, before insertion of brachytherapy seeds in the prostate, an injection of hyaluronic acid between the prostate, rectum, and pudendal arteries

Conventional brachytherapy; hyaluronic acid arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Centre Jean François Leclerc

Dijon, 21079, France

Location

Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single Blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 26, 2019
• Study Start: October 5, 2021
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)