Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT05884632
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2030-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute gastrointestinal toxicity', 'timeFrame': '90 days from the RT treatment', 'description': 'Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.'}], 'secondaryOutcomes': [{'measure': 'Acute genitourinary toxicity', 'timeFrame': '90 days from the RT treatment.', 'description': 'Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.'}, {'measure': 'Late toxicity', 'timeFrame': 'From 90 days after the RT treatment until 24 months', 'description': 'Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.'}, {'measure': 'QLQ-C30', 'timeFrame': 'At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months', 'description': 'Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months'}, {'measure': 'Biochemical failure', 'timeFrame': '24 months', 'description': 'PSA raise after RT from nadir'}, {'measure': 'Time to biochemical failure', 'timeFrame': '24 months', 'description': 'Time between salvage RT and biochemical failure'}, {'measure': 'Local in-field relapse', 'timeFrame': '24 months', 'description': 'Local in-field relapse evaluated with PET-CT or RM'}, {'measure': 'Metastases-free survival', 'timeFrame': '24 months', 'description': 'Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.\n\nPatients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≤ 80 years;\n* Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);\n* Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \\<0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;\n* No distant metastases (M0) diagnosed with PSMA-PET-CT;\n* Informed consent to trial's participation and personal data treatment.\n\nExclusion Criteria:\n\n* Age \\<18 years old;\n* Adjuvant radiotherapy;\n* Previous radiation in the same anatomical site."}, 'identificationModule': {'nctId': 'NCT05884632', 'acronym': 'DART-PHASER', 'briefTitle': 'Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Sacro Cuore Don Calabria di Negrar'}, 'officialTitle': 'Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients', 'orgStudyIdInfo': {'id': '2022-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy', 'interventionNames': ['Radiation: Daily Adaptive RadioTherapy']}], 'interventions': [{'name': 'Daily Adaptive RadioTherapy', 'type': 'RADIATION', 'description': 'Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Nicosia, Doctor', 'role': 'CONTACT', 'email': 'luca.nicosia@sacrocuore.it', 'phone': '+39(0)456014800'}], 'facility': 'IRCCS Sacro Cuore Don Calabria di Negrar', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}], 'centralContacts': [{'name': 'Elvia Malo', 'role': 'CONTACT', 'email': 'ricerca.clinica@sacrocuore.it', 'phone': '+390456014854'}], 'overallOfficials': [{'name': 'Luca Nicosia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Sacro Cuore Don Calabria di Negrar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}