Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 1:27 PM
Study NCT ID:
NCT06523634
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-inferiority randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-07-23', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SBRT impact on patient-reported GI and GU symptoms', 'timeFrame': '2 years post treatment', 'description': 'Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes', 'timeFrame': 'at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years', 'description': 'Patient-reported outcomes according to the different\n\n* EPIC-26 domains (0-100)\n* IPSS score (0-35)\n* EQ-5D-5L scores (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)'}, {'measure': 'Ccost-utility during radiotherapy', 'timeFrame': 'during radiotherapy', 'description': 'Cost-utility analysis based on EQ-5D-5L (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)versus costs of RT and transportation during radiotherapy'}, {'measure': 'Physician-scored toxicity', 'timeFrame': 'up to 5 years', 'description': 'Physician-scored toxicity according to CTCAE 5.0 (grades) (Early: within 90 days; or late: 90 or more days after SBRT). Proportion of patients with G2+ toxicity will be reported specifically.'}, {'measure': 'Blood lymphocyte evolution between study arms', 'timeFrame': '5 years', 'description': 'Lymphocyte count nadir relative to baseline'}, {'measure': 'To compare biochemical progression-free survival (bPFS) to historical control and between study arms', 'timeFrame': '5 years', 'description': 'Biochemical progression-free survival (bPFS)'}, {'measure': 'To compare local and regional recurrences between study arms, up to 5 years.', 'timeFrame': '5 years', 'description': 'Local and regional control'}, {'measure': 'To compare Overall survival (OS) between study arms, up to 5 years.', 'timeFrame': '5 years', 'description': 'Overall survival (OS)'}, {'measure': 'To compare distant metastases-free survival (dmFS) between study arms', 'timeFrame': '5 years', 'description': 'Distant metastases-free survival (dmFS).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.', 'detailedDescription': 'This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.\n\nAll subjects will be randomly assigned in a 1:1 ratio:\n\n1. Experimental arm: Radiotherapy treatment in 5 fractions.\n2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.\n2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \\>0.1 ng/mL , or three consecutive PSA rises)\n3. WHO PS 0-1\n4. Age ≥18 years\n5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry\n6. Ability to understand and answer the EPIC-26 form in one of the languages available\n\nEXCLUSION CRITERIA\n\n1. Patients with a pT4 tumor at prostatectomy\n2. Patients with previously pathologically confirmed N1\n3. Patients with macroscopically involved margin at surgery (R2)\n4. Patients with a history of distant metastases\n5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \\>1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.\n6. Latest PSA \\> 2ng/ml\n7. Patients with a IPSS \\>20\n8. Gleason 10 tumor\n9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate\n10. Prior pelvic radiotherapy\n11. Prior hormonal therapy started more than 6 weeks before randomization\n12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.\n13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.'}, 'identificationModule': {'nctId': 'NCT06523634', 'acronym': 'STEREOBED', 'briefTitle': 'Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.', 'orgStudyIdInfo': {'id': 'CE3764'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard of care radiotherapy', 'interventionNames': ['Radiation: SOC RT']}, {'type': 'EXPERIMENTAL', 'label': 'SBRT', 'description': 'SBRT: 5 fractions', 'interventionNames': ['Radiation: Stereotactic body radiotherapy (SBRT)']}], 'interventions': [{'name': 'Stereotactic body radiotherapy (SBRT)', 'type': 'RADIATION', 'description': '5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.', 'armGroupLabels': ['SBRT']}, {'name': 'SOC RT', 'type': 'RADIATION', 'description': 'Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules:\n\n* Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks))\n* Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Benedikt Engels, MD PhD', 'role': 'CONTACT', 'email': 'radiotherapie@azorg.be', 'phone': '053 72 86 66'}], 'facility': 'AZorg', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Piet Dirix, MD PhD', 'role': 'CONTACT', 'email': 'gza.iridiumnetwerk@zas.be', 'phone': '03 443 37 37'}], 'facility': 'Ziekenhuis Aan de Stroom (ZAS)', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sabine Meersschout, MD', 'role': 'CONTACT', 'email': 'radiotherapie.brugge@azsintjan.be', 'phone': '+3250 45 28 00'}], 'facility': 'AZ Sint Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Nicolas Jullian, MD', 'role': 'CONTACT', 'phone': '+3225413832'}], 'facility': 'Jules Bordet Institute, H.U.B', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Genk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laura Vandenbergh, MD', 'role': 'CONTACT', 'email': 'info@zol.be', 'phone': '+32 89 80 83 30'}], 'facility': 'Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Philippe Bulens, MD', 'role': 'CONTACT', 'email': 'info@jessazh.be', 'phone': '011 33 79 79'}], 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Kortrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Nora Sundahl, MD PhD', 'role': 'CONTACT', 'email': 'radiotherapie@azgroeninge.be', 'phone': '+3256 63 39 03'}], 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'La Louvière', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Samuel Palumbo, MD', 'role': 'CONTACT', 'email': 'info@helora.be', 'phone': '064 23 41 88'}], 'facility': 'CHU HELORA - Hôpital de La Louvière - site Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'city': 'Mechelen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Cédric Draulans, MD', 'role': 'CONTACT', 'email': 'azsintmaarten@emmaus.be', 'phone': '015 89 29 80'}], 'facility': 'AZ Sint-Maarten', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'city': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Paul Nguyen, MD', 'role': 'CONTACT', 'email': 'sormn.se@chuuclnamur.uclouvain.be', 'phone': '+32 (0)81 72 05 25'}], 'facility': 'CHU UCL Namur - Site Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'city': 'Woluwe-Saint-Lambert', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Ad Vandermeulen, MD', 'role': 'CONTACT', 'email': 'contact-patient@saintluc.uclouvain.be', 'phone': '+32 2 764 47 52'}], 'facility': 'Cliniques universitaires Saint-Luc (UCLouvain)', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}], 'centralContacts': [{'name': 'Robbe Van den Begin, MD, PhD', 'role': 'CONTACT', 'email': 'robbe.vandenbegin@hubruxelles.be', 'phone': '+3225413832'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}