Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04997018
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2021-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 91}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of pretreatment biopsy with post-treatment biopsy', 'timeFrame': '24 months', 'description': 'The primary outcome of efficacy will be studied using post -treatment biopsies. To demonstrate efficacy of dose escalation to the DIL, the investigators aim to reduce the positive post-treatment biopsy rates at 24 months for intermediate risk disease from 20% to 10%.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SBRT', 'stereotactic body radiation therapy', 'prostate cancer', '21-308', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:\n\n * PSA 10-20 ng/ml or\n * Gleason score = 7 or\n * Clinical stage T2b/T2c or\n* Additionally, patients will be required to meet all of the following criteria:\n\n * Age ≥ 18\n * Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)\n * Prostate size ≤ 80 cc\n * Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus\n * MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted\n * International Prostate Symptom Score ≤ 15\n * Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form\n\nExclusion Criteria:\n\nPatient will be excluded if they meet any one of the following criteria:\n\n* Gleason score \\>7\n* PSA \\>20\n* Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE\n* MRI findings: \\>2 disease foci identifiable\n* Evidence of metastatic disease on bone scan or MRI/CT\n* MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.\n* Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI\n* Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction\n* Contra-indications to receiving gadolinium contrast\n* KPS \\< 80\n* Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease\n* Prior history of transurethral resection of the prostate\n* Prior history of urethral stricture\n* Prior history of pelvic irradiation\n* History of inflammatory bowel disease\n* Unable to give informed consent\n* Unable to complete quality of life questionnaires\n* Abnormal complete blood count, including any of the following:\n\n * Platelet count less than 75,000/ml\n * Hb level less than 10 gm/dl\n * WBC less than 3.5/ml\n* Abnormal renal function tests (creatinine \\> 1.5)'}, 'identificationModule': {'nctId': 'NCT04997018', 'briefTitle': 'A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy', 'orgStudyIdInfo': {'id': '21-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prostate cancer patients', 'description': 'Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:\n\n* PSA 10-20 ng/ml or\n* Gleason score = 7\n* Clinical stage T2b/T2c', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['SBRT'], 'description': 'Patients enrolled in this study will undergo ultra-hypofractionated radiation utilizing MR guided, daily online adaptive planning. Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously-delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm, as determined on the pretreatment diagnostic T2 MRI imaging. In the setting of two similarly-sized "dominant" lesions, both will be boosted.', 'armGroupLabels': ['Prostate cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'phone': '212-639-8904'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}], 'facility': 'Victoria Brennan', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'CONTACT', 'email': 'brennanv@mskcc.org', 'phone': '212-639-8904'}, {'name': 'Michael Zelefsky, MD', 'role': 'CONTACT', 'email': 'zelefskm@MSKCC.ORG', 'phone': '212-639-6802'}], 'overallOfficials': [{'name': 'Victoria Brennan, MBBCH BAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}