Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT06625034
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of 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': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D017785', 'term': 'Photons'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2033-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)', 'timeFrame': 'Up to 3 months post-radiotherapy', 'description': 'AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events at 3 months post-radiotherapy for prostate cancer.\n\nEXPLORATORY OBJECTIVES:\n\nI. After completion of radiation therapy, determine the incidence of:\n\nIa. Grade 2 or greater GU and GI toxicity at 3 months (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5); Ib. Quality of life 3 months post-radiotherapy; Ic. Rate of achieving dose-volume constraints. II. Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A (HUMAN-DRIVEN): Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo magnetic resonance imaging (MRI) pre-treatment and blood sample collection and positron emission tomography (PET) throughout study.\n\nARM B (KNOWLEDGE-BASED): Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.\n\nAfter completion of study treatment, patients are followed up at 3 and 12 months then yearly for up to year 5.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be at least 18 years old\n* Histologically confirmed prostate cancer\n* Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer \\[AJCC\\] criteria 8th edition \\[Ed\\])\n* Planned definitive dose radiotherapy to the prostate or prostate bed\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment\n* Patients must sign Institutional Review Board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (radiation) within 180 days of study registration\n* In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome\n\nExclusion Criteria:\n\n* Previous pelvic radiation \\> 5 Gy\n* Planned delivery of radiotherapy to pelvic lymph nodes\n* Planned delivery of brachytherapy of the prostate\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior hip replacement or penile implant\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)\n* Indwelling or intermittent urinary catheter use"}, 'identificationModule': {'nctId': 'NCT06625034', 'briefTitle': 'Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy', 'orgStudyIdInfo': {'id': 'GMROA2451'}, 'secondaryIdInfos': [{'id': 'NCI-2024-07870', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '24-006449', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}, {'id': 'GMROA2451', 'type': 'OTHER', 'domain': 'Mayo Clinic Radiation Oncology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (human-driven treatment planning, radiation therapy)', 'description': 'Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Magnetic Resonance Imaging', 'Radiation: Photon Beam Radiation Therapy', 'Procedure: Positron Emission Tomography', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy Treatment Planning and Simulation']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (RapidPlan treatment planning, radiation therapy)', 'description': 'Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Magnetic Resonance Imaging', 'Radiation: Photon Beam Radiation Therapy', 'Procedure: Positron Emission Tomography', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy Treatment Planning and Simulation']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)', 'Arm B (RapidPlan treatment planning, radiation therapy)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)', 'Arm B (RapidPlan treatment planning, radiation therapy)']}, {'name': 'Photon Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['External beam radiation therapy using photons (procedure)', 'Photon', 'Photon EBRT', 'Photon External Beam Radiotherapy', 'PHOTON Therapy', 'Radiation, Photon Beam'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)', 'Arm B (RapidPlan treatment planning, radiation therapy)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging', 'PT'], 'description': 'Undergo PET', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)', 'Arm B (RapidPlan treatment planning, radiation therapy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)', 'Arm B (RapidPlan treatment planning, radiation therapy)']}, {'name': 'Radiation Therapy Treatment Planning and Simulation', 'type': 'RADIATION', 'otherNames': ['Radiation Therapy Treatment Planning/Simulation'], 'description': 'Receive human-driven treatment planning', 'armGroupLabels': ['Arm A (human-driven treatment planning, radiation therapy)']}, {'name': 'Radiation Therapy Treatment Planning and Simulation', 'type': 'RADIATION', 'otherNames': ['Radiation Therapy Treatment Planning/Simulation'], 'description': 'Receive RapidPlan treatment planning', 'armGroupLabels': ['Arm B (RapidPlan treatment planning, radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Nathan Y. Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Nathan Y. Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}