Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-16 @ 10:03 AM
Study NCT ID:
NCT02165020
Status:
UNKNOWN
Last Update Posted:
2016-10-05
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid for Hypofractionated Prostate Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.', 'timeFrame': '3 years', 'description': 'Number of patients with acute rectal toxicities of all grades and of grade ≥ 2 (using the CTCAE v 4.0), as a measure of safety and tolerability.'}, {'measure': 'Tolerance of the HA injection', 'timeFrame': '3 years', 'description': 'The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).'}, {'measure': 'Number of patients with acute and late toxicities, other than the rectal toxicities.', 'timeFrame': '3 years', 'description': 'Number of patients with acute and late toxicities (using the CTCAE v 4.0), other than the rectal toxicities, as a measure of safety and tolerability.'}, {'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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate', 'Hypofractionated radiotherapy', 'Hyaluronic acid', 'Spacer', 'Rectum toxicity', 'Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age superior or equal to 18 years and inferior to 80 years.\n* patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.\n* prostate cancer histologically proven.\n* life expectancy superior to 10 years.\n* Karnofsky performance status ≥ 60% (performance status ECOG 0-2).\n* the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).\n* the signed consent form.\n\nExclusion Criteria:\n\n* age inferior to 18 years and ≥ 80 years;\n* history of rectal surgery;\n* patient who can't cooperate during the treatment;\n* history of pelvic irradiation;\n* history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;\n* other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;\n* 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);\n* patients receiving anticoagulant treatment or PLAVIX;\n* other undergoing study that may interfere with the present study;\n* patient under legal protection measure."}, 'identificationModule': {'nctId': 'NCT02165020', 'acronym': 'RPAH1', 'briefTitle': 'Hyaluronic Acid for Hypofractionated Prostate Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection', 'orgStudyIdInfo': {'id': '2010-606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rectal toxicities after prostate hypofractionated radiotherapy', 'description': 'Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid', 'interventionNames': ['Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)']}], 'interventions': [{'name': 'Hyaluronic acid (Macrolane VRF 30®, Q-MED)', 'type': 'DEVICE', 'description': 'One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound.\n\nThe injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle.', 'armGroupLabels': ['Rectal toxicities after prostate hypofractionated radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69002', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}