Clinical trial NCT04105920: Evaluation of the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies
Official title: Phase III Trial Randomized to Evaluate the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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). The overall survival and survival rates without biochemical recurrence at 5 and 10 years are comparable to those of other techniques such as prostatectomy or external radiotherapy (RTE), exceeding 95%.

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 (18.5% moderate erectile dysfunction at 2 years, for moderate to severe degradation rates usually seen between 30 and 70% after external beam radiotherapy. 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.

Eligibility 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

Primary outcomes:
measure: interest of Hyalurocnic injection to protect pudendal arteries during prostate brachytherapy in the preservation of Erectile function at 2years.
timeFrame: 2 years
Secondary outcomes:
measure: Evolution of erectile function.
timeFrame: 2 years
measure: The IPDE5 consumption at 2 years
timeFrame: 2 years
measure: Erection satisfaction at 2 years
timeFrame: 2 years
Other outcomes:
measure: Psychosocial dimensions
timeFrame: 2 years
measure: Response assessment of IPDE5 (Phosphodiesterase 5 inhibitors ) treatement.
timeFrame: 6 months
measure: The incidence of acute gastrointestinal and gastrourinary toxicity
timeFrame: 6 months
measure: The incidence of late gastrointestinal and gastrourinary toxicity,
timeFrame: 2 years
measure: Evaluation of brachytherapy by CT-MRI fusion Imaging measuring
timeFrame: 45 days after brachytherapy
measure: Thickness hyaluronique acide injection assessment
timeFrame: 24 hours after surgery
measure: Link between hyaluronic acid and pudendal artery stenosis.
timeFrame: 2 years after treatment
measure: Link between pudendal artheris stenosis occurrence and radiation dose received
timeFrame: 2 years after surgery
measure: Link between pudendal arteries stenosis and erectile disfunction.
timeFrame: 2 years after treatment
Locations:
city: Dijon
country: France
facility: Centre Jean François Leclerc
city: Grenoble
country: France
facility: Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
city: Pierre-Bénite cedex
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References: