Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-23 @ 12:23 PM
Study NCT ID:
NCT06491056
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
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': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D018274', 'term': 'Electroporation'}, {'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Formalin-Fixed Paraffin-Embedded (FFPE) Biopsy specimens of each cancerous lesion identified within the prostate.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2048-05-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2023-07-03', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inter-modality Comparison of short-term Oncological Outcomes', 'timeFrame': '12 months', 'description': 'Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities'}, {'measure': 'Inter-modality Comparison of Conversion to Radical Treatment Rates', 'timeFrame': '10 years', 'description': 'Comparison of 10 year conversion to radical treatment (Radical Prostatecomy or Radiation) between different modalities'}, {'measure': 'Inter-modality Comparison of Treatment Failure Rates', 'timeFrame': '10 years', 'description': 'Comparison of 10 year failure (Radical Prostatectomy or Radiation or Hormonal Therapy or transition to Watchful Waiting) between different modalities'}, {'measure': 'Inter-modality Comparison of Metastasis Rates', 'timeFrame': '10 years', 'description': 'Comparison of 10 year metastasis-rate between different modalities'}, {'measure': 'Inter-modality Comparison of Sexual Function Outcomes', 'timeFrame': '12 months', 'description': 'Comparing mean change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.'}, {'measure': 'Inter-modality Comparison of Urinary Function Outcomes', 'timeFrame': '12 months', 'description': 'Comparing mean change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.'}, {'measure': 'Inter-modality Comparison of Bowel Function Outcomes', 'timeFrame': '12 months', 'description': 'Comparing mean change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '20 years', 'description': 'Living at 20 years after treatment'}, {'measure': 'Metastasis-Free Survival', 'timeFrame': '20 years', 'description': 'Metastasis Free at 20 years after treatment'}, {'measure': 'Progression-Free Survival', 'timeFrame': '20 years', 'description': 'Progression-Free (Local or Systemic) at 20 years after treatment'}, {'measure': 'Short-term Clinically Significant Prostate Cancer Recurrence', 'timeFrame': '18 months', 'description': '12-18 month infield and outfield recurrence rate'}, {'measure': 'Intermediate-term Clinically Significant Prostate Cancer Recurrence', 'timeFrame': '5 years', 'description': '5 year infield and outfield recurrence rate'}, {'measure': 'Sexual Function', 'timeFrame': '12 months', 'description': 'Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months'}, {'measure': 'Urinary Function', 'timeFrame': '12 months', 'description': 'Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months'}, {'measure': 'Bowel Function', 'timeFrame': '12 months', 'description': 'Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months'}, {'measure': 'Radical Intervention-free Survival', 'timeFrame': '5 years', 'description': 'Free of Radical Prostatectomy or Radiation at 5 years'}, {'measure': 'Treatment Failure-free Survival', 'timeFrame': '5 years', 'description': 'Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years'}], 'secondaryOutcomes': [{'measure': 'Intervention-Free Survival', 'timeFrame': '20 years', 'description': 'Intervention (Focal or Whole Gland/ Radical)-free at 20 years'}, {'measure': 'Radical Intervention-Free Survival', 'timeFrame': '20 years', 'description': 'Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years'}, {'measure': 'Failure-Free Survival', 'timeFrame': '10 years', 'description': 'Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years'}, {'measure': 'Failure-Free Survival', 'timeFrame': '20 years', 'description': 'Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['focal therapy', 'cryotherapy', 'high intensity focused ultrasound', 'irreversible electroporation', 'focal laser ablation', 'Microwave ablation'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36083229', 'type': 'BACKGROUND', 'citation': 'Ong S, Chen K, Grummet J, Yaxley J, Scheltema MJ, Stricker P, Tay KJ, Lawrentschuk N. Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus? BJU Int. 2023 Jan;131(1):20-31. doi: 10.1111/bju.15883. Epub 2022 Sep 27.'}, {'pmid': '28349978', 'type': 'BACKGROUND', 'citation': 'Tay KJ, Scheltema MJ, Ahmed HU, Barret E, Coleman JA, Dominguez-Escrig J, Ghai S, Huang J, Jones JS, Klotz LH, Robertson CN, Sanchez-Salas R, Scionti S, Sivaraman A, de la Rosette J, Polascik TJ. Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project. Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. doi: 10.1038/pcan.2017.8. Epub 2017 Mar 28.'}, {'pmid': '36895163', 'type': 'RESULT', 'citation': 'Tan YG, Law YM, Ngo NT, Khor LY, Tan PH, Ong EHW, Yuen JSP, Ho HSS, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Chua MLK, Polascik TJ, Tay KJ. Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study. Prostate. 2023 Jun;83(8):781-791. doi: 10.1002/pros.24517. Epub 2023 Mar 9.'}, {'pmid': '28654336', 'type': 'RESULT', 'citation': 'Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Nov;285(2):620-628. doi: 10.1148/radiol.2017161650. Epub 2017 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia', 'detailedDescription': 'Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with limited volume prostate cancer undergoing focal therapy (FT).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate Adenocarcinoma\n* Maximum Gleason score 4+4\n* Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)\n* Maximum Prostate Specific Antigen (PSA) level 15 ng/dl\n* Maximum clinical stage T2c\n* American Society of Anesthesiologist Criteria 2 or less\n\nExclusion Criteria:\n\n* Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted'}, 'identificationModule': {'nctId': 'NCT06491056', 'acronym': 'ProAMFocal', 'briefTitle': 'Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer', 'orgStudyIdInfo': {'id': 'CIRB 2023/2055'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focal Therapy for Prostate Cancer', 'description': 'Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of \\<75% of the prostate gland.', 'interventionNames': ['Device: Focal Therapy for Prostate Cancer']}], 'interventions': [{'name': 'Focal Therapy for Prostate Cancer', 'type': 'DEVICE', 'otherNames': ['Cryotherapy', 'High Intensity Focused Ultrasound (HIFU)', 'Irreversible Electroporation (IRE)', 'Nanoknife', 'HIFU', 'Cryoablation', 'Laser', 'Microwave ablation'], 'description': 'Ablation of \\<75% of the prostate gland for limited volume prostate cancer', 'armGroupLabels': ['Focal Therapy for Prostate Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169856', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Kae Jack Tay, MBBS', 'role': 'CONTACT', 'email': 'tay.kae.jack@singhealth.com.sg', 'phone': '63214693'}, {'name': 'Kae Jack Tay, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Kae Jack Tay, MBBS', 'role': 'CONTACT', 'email': 'tay.kae.jack@singhealth.com.sg', 'phone': '63214693'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Medical Research Council (NMRC), Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}