Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT05804318
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daily Adaptive Radiation Therapy Using an Individualized Approach for 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': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-03-26', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Decipher prognostic ability', 'timeFrame': '5 years after end of SBRT', 'description': 'Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.'}], 'primaryOutcomes': [{'measure': 'Patient-reported acute urinary toxicity', 'timeFrame': '90 days after end of SBRT', 'description': 'Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.'}], 'secondaryOutcomes': [{'measure': 'Freedom from biochemical recurrence', 'timeFrame': '5 years after end of SBRT', 'description': 'Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)'}, {'measure': 'Patient-reported quality of life issues related to prostate cancer.', 'timeFrame': 'Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.'}, {'measure': 'Patient-reported erectile dysfunction symptoms', 'timeFrame': 'Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.'}, {'measure': 'Patient-reported urinary symptoms', 'timeFrame': 'Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.'}, {'measure': 'Patient-reported overall quality of life', 'timeFrame': 'Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.'}, {'measure': 'Physician-reported toxicities', 'timeFrame': 'During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Physician-reported CTCAE v 5.0 adverse events'}, {'measure': 'Alpha-blocker medication use', 'timeFrame': 'Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT', 'description': 'Change in use of alpha-blocker medications for urinary symptoms'}, {'measure': 'Metastasis-free survival', 'timeFrame': '5 years after end of SBRT', 'description': 'Metastasis-free survival'}, {'measure': 'Prostate-cancer specific mortality', 'timeFrame': '5 years after end of SBRT', 'description': 'Prostate-cancer specific mortality'}, {'measure': 'Overall survival', 'timeFrame': '5 years after end of SBRT', 'description': 'Overall survival'}, {'measure': 'Workflow metrics of adaptive SBRT for prostate cancer', 'timeFrame': '2 weeks after start of SBRT', 'description': 'Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.'}, {'measure': 'Target and OAR dosimetry', 'timeFrame': '2 weeks after start of SBRT', 'description': 'Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry'}, {'measure': 'Impact of rectal spacers', 'timeFrame': 'Enrollment through 5 year follow up', 'description': 'Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.\n2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.\n3. AUA/IPSS score is ≤ 15.\n4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%).\n5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).\n6. Patient has the ability to complete required patient questionnaires.\n7. Patient age ≥ 18 years (or greater than the local age of majority).\n8. Patient has the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has baseline grade ≥3 GI or GU toxicity\n2. Patient has had prior overlapping pelvic radiotherapy.\n3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.\n4. Patient has node positive prostate cancer.\n5. Patient has extracapsular extension (capsular abutment is permitted).\n6. Patient has active inflammatory bowel disease or active collagen vascular disease.\n7. Patient cannot undergo prostate MRI.\n8. Patient cannot undergo prostate fiducial marker placement.\n9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).'}, 'identificationModule': {'nctId': 'NCT05804318', 'acronym': 'ARTIA-Prostate', 'briefTitle': 'Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Varian, a Siemens Healthineers Company'}, 'officialTitle': 'Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity', 'orgStudyIdInfo': {'id': 'VAR-2021-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive SBRT with Urethral Sparing', 'description': 'Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra.', 'interventionNames': ['Device: Daily adaptive SBRT with urethral sparing']}], 'interventions': [{'name': 'Daily adaptive SBRT with urethral sparing', 'type': 'DEVICE', 'description': 'The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.', 'armGroupLabels': ['Adaptive SBRT with Urethral Sparing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Percy Lee, MD', 'role': 'CONTACT', 'email': 'percylee@coh.org', 'phone': '833-672-4068'}], 'facility': 'Duarte Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Percy Lee, MD', 'role': 'CONTACT', 'email': 'percylee@coh.org', 'phone': '833-672-4068'}], 'facility': 'City of Hope Orange County Lennar Foundation Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sinead Christensen', 'role': 'CONTACT', 'email': 'smchristensen@bwh.harvard.edu', 'phone': '617-582-8264'}, {'name': 'Kris Zhai', 'role': 'CONTACT', 'email': 'bkzhai@bwh.harvard.edu', 'phone': '(617) 582-8996'}, {'name': 'Jonathan Leeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsey Mayer, CCRP', 'role': 'CONTACT', 'email': 'lindseymayer@wustl.edu', 'phone': '314-482-9202'}, {'name': 'James Randall, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Hecht, MD', 'role': 'CONTACT', 'email': 'markus.hecht.clinicaltrials@uks.eu', 'phone': '0049 6841 16 24874'}, {'name': 'Wiebke Pirschel, MSc', 'role': 'CONTACT', 'email': 'wiebke.pirschel@uks.eu', 'phone': '0049 6841 16 24874'}, {'name': 'Markus Hecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Barrado Los Arcos, MD PhD', 'role': 'CONTACT', 'email': 'marta.barrado.losarcos@navarra.es', 'phone': '0034-848-488482'}, {'name': 'Elena Villafranca Iturre, MD', 'role': 'CONTACT', 'email': 'elena.villafranca.iturre@navarra.es', 'phone': '0034-848-488482'}], 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'Sean Davidson, MASc', 'role': 'CONTACT', 'email': 'sean.davidson@varian.com', 'phone': '1-437-991-8294'}, {'name': 'Claire McCann, PhD', 'role': 'CONTACT', 'email': 'claire.mccann@varian.com'}], 'overallOfficials': [{'name': 'Jonathan Leeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Jeremy Bredfeldt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Varian, a Siemens Healthineers Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}