Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-01 @ 11:48 PM
Study NCT ID:
NCT04984395
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bone marrow biopsy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis: WBMRI parameters', 'timeFrame': 'Month 1-26', 'description': 'Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival.'}, {'measure': 'Retrospective analysis: Diagnostic performance of MET-RADS-P', 'timeFrame': 'Month 1-26', 'description': 'Accuracy of MET-RADS-P to assess response to systemic treatment.'}, {'measure': 'Single centre prospective observational imaging study', 'timeFrame': 'Month 6-38', 'description': 'Pairwise correlations of percentage of ADC change with:\n\n1. Tumour regression grading according to the international system of Salzer-Kuntschnik\n2. Changes in biopsy tumour content and tumour/necrosis ratio\n3. Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis.'}], 'secondaryOutcomes': [{'measure': 'Retrospective analysis: WBMRI parameters', 'timeFrame': 'Month 1-26', 'description': 'Prognostic association of baseline tDV and ADC for prediction of radiographic Progression Free Survival (rPFS) using Prostate Cancer Working Group 3 criteria (PCWG3) and Skeletal Related Events (SREs).'}, {'measure': 'Retrospective analysis: Diagnostic performance of MET-RADS-P', 'timeFrame': 'Month 1-26', 'description': 'Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival.'}, {'measure': 'Single centre prospective observational imaging study', 'timeFrame': 'Month 6-38', 'description': 'Fraction of bone biopsies with sufficient tumour yield for genomic sequencing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.', 'detailedDescription': 'Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic, advanced prostate cancer.', 'genderDescription': 'Male with prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRetrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.\n\nRetrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment\n\nProspective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.\n\nParticipants must have a baseline WBMRI and CT-guided bone marrow biopsy.\n\nExclusion Criteria:\n\nProspective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).'}, 'identificationModule': {'nctId': 'NCT04984395', 'acronym': 'IDT', 'briefTitle': 'Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging', 'orgStudyIdInfo': {'id': 'CCR5459'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Post-treatment CT-guided bone marrow biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'contacts': [{'name': 'Ana Ribeiro', 'role': 'CONTACT', 'email': 'ana.ribeiro@rmh.nhs.uk', 'phone': '02089156499'}, {'name': 'Tiaan Jacobs', 'role': 'CONTACT', 'email': 'tiaan.jacobs@rmh.nhs.uk'}, {'name': 'Dow-Mu Koh, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nina Tunariu, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Johann DeBono, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'centralContacts': [{'name': 'Ana Ribeiro', 'role': 'CONTACT', 'email': 'ana.ribeiro@rmh.nhs.uk', 'phone': '02089156499'}, {'name': 'Tiaan Jacobs', 'role': 'CONTACT', 'email': 'tiaan.jacobs@rmh.nhs.uk', 'phone': '02089156499'}], 'overallOfficials': [{'name': 'Nina Tunariu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Marsden NHS FT'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Fully anonymised trial data will be made available.', 'ipdSharing': 'YES', 'description': 'The main study results will be published in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, consisting of members of the Study Management Group.', 'accessCriteria': 'Data Sharing / Transfer Agreements to be in place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}