Clinical trial NCT02165020: Hyaluronic Acid for Hypofractionated Prostate Radiotherapy
Official title: Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Hypofractionated radiotherapy
Hyaluronic acid
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Rectum toxicity
Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.


Eligibility criteria: Inclusion Criteria:

* age superior or equal to 18 years and inferior to 80 years.
* patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
* prostate cancer histologically proven.
* life expectancy superior to 10 years.
* Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
* the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
* the signed consent form.

Exclusion Criteria:

* age inferior to 18 years and ≥ 80 years;
* history of rectal surgery;
* patient who can't cooperate during the treatment;
* history of pelvic irradiation;
* history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
* other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
* patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect);
* patients receiving anticoagulant treatment or PLAVIX;
* other undergoing study that may interfere with the present study;
* patient under legal protection measure.

Primary outcomes:
measure: Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.
timeFrame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Secondary outcomes:
measure: Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.
timeFrame: 3 years
measure: Tolerance of the HA injection
timeFrame: 3 years
measure: Number of patients with acute and late toxicities, other than the rectal toxicities.
timeFrame: 3 years
measure: The evaluation of the biochemical control
timeFrame: 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References: