Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT06220435
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade 3+ Genitourinary Adverse Events', 'timeFrame': 'start of treatment - 5 years', 'description': 'Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.'}], 'secondaryOutcomes': [{'measure': 'Grade 2+ Genitourinary Adverse Events', 'timeFrame': 'start of treatment - 5 years', 'description': 'Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.'}, {'measure': 'Failure-free survival', 'timeFrame': 'consent date - 5 years'}, {'measure': 'Local failure-free survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Biochemical failure-free survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Cancer-specific survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Overall survival failure-free survival, cancer-specific survival, and overall survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival', 'timeFrame': 'enrollment date - 5 years'}, {'measure': 'Adverse Events according to CTCAE v5.0', 'timeFrame': 'start of treatment - 5 years'}, {'measure': 'Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30)', 'timeFrame': 'inclusion date - 5 years', 'description': 'All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems'}, {'measure': 'Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25)', 'timeFrame': 'inclusion date - 5 years', 'description': 'It includes subscales assessing urinary symptoms, bowel symptom), treatment-related symptom) and sexual functioning with score from 0 to 4 per item. A high scale score represents a higher response level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['very high risk prostate cancer', 'radiotherapy', 'localized prostate cancer treatment', 'ultra-hypofractionated radiation boost'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.', 'detailedDescription': 'HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.\n\nSpecific aims of the study are:\n\n* To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).\n* To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.\n* To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy \\>5 years\n* Age ≥18 years\n* World Health Organization (WHO) performance status 0-2\n* Histological evidence of prostate cancer\n* Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L\n* At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)\n* Patients must be able to comply with the protocol\n* Signed informed consent\n* Adequate laboratory findings: haemoglobin (Hb) \\>90 g/L, absolute neutrophil count \\>1.0x10\\^9/l, platelets \\>75x10\\^9/l, bilirubin \\<2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) \\<5x ULN and creatinine \\<2.0x ULN)\n\nExclusion Criteria:\n\n* Regional or distant metastasis\n* Any contraindications for MRI\n* PSA \\>150 ng/ml\n* Previous pelvic radiotherapy\n* Prior prostate surgery including transurethral resection of the prostate (TURP)\n* Endocrine treatment (past or present)\n* Other malignancies than prostate cancer and basalioma in the past five years\n* Serious disease state that makes study inclusion and treatment unsuitable\n* Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)'}, 'identificationModule': {'nctId': 'NCT06220435', 'briefTitle': 'Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)', 'orgStudyIdInfo': {'id': 'HYPO-RT-PC boost'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HYPO-RT-PC boost', 'description': 'Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.', 'interventionNames': ['Radiation: Ultra-hypofractionated radiotherapy regimen.']}], 'interventions': [{'name': 'Ultra-hypofractionated radiotherapy regimen.', 'type': 'RADIATION', 'description': '* Prostate tumor(s): 49 Gray (Gy)/7 fractions\n* Prostate gland: 42.7 Gy/7 fractions\n* Elective lymph nodes: 29.4 Gy/7 fractions\n* Seminal vesicles: 31.15 Gy/7 fractions', 'armGroupLabels': ['HYPO-RT-PC boost']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Adalsteinn Gunnlaugsson, MD, PhD', 'role': 'CONTACT', 'email': 'Adalsteinn.Gunnlaugsson@skane.se', 'phone': '+46 4617 6268'}, {'name': 'Clinical Trials Office', 'role': 'CONTACT', 'email': 'cto.hematologi_onkologi.se@skane.se'}], 'facility': 'Region Skåne, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Umeå', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Karin Söderkvist, MD, PhD', 'role': 'CONTACT', 'email': 'karin.soderkvist@umu.se', 'phone': '+46907851000'}], 'facility': 'Region Västerbotten, Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Adalsteinn Gunnlaugsson, MD, PhD', 'role': 'CONTACT', 'email': 'Adalsteinn.Gunnlaugsson@skane.se', 'phone': '+46 4617 6268'}, {'name': 'HYPO-RT-PC boost Clinical Trials Office', 'role': 'CONTACT', 'email': 'cto.hematologi_onkologi.se@skane.se', 'phone': '+46 4617 8559'}], 'overallOfficials': [{'name': 'Adalsteinn Gunnlaugsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skåne, Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}