Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-30 @ 8:37 AM
Study NCT ID:
NCT05223803
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TERPS Trial for de Novo Oligometastic 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.', 'timeFrame': '2 years', 'description': 'Cross-over to the SABR MDT is allowed following failure.'}], 'secondaryOutcomes': [{'measure': 'To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease', 'timeFrame': '5 years', 'description': 'Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.'}, {'measure': 'To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.', 'timeFrame': '1 year'}, {'measure': 'To assess time to progression', 'timeFrame': '5 years', 'description': 'Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT).'}, {'measure': 'Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.', 'timeFrame': '5 years', 'description': 'EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Oligometastatic Disease']}, 'descriptionModule': {'briefSummary': 'This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.', 'detailedDescription': 'This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.\n\n 1. CT or MRI scan within 6 months of enrollment\n 2. Bone scan within 6 months of enrollment\n 3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)\n2. Histologic confirmation of malignancy (primary or metastatic tumor).\n3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.\n4. PSA \\> 0.5 but \\<100.\n5. Patient must be ≥ 18 years of age.\n6. Patient must have a life expectancy ≥ 12 months.\n7. Patient must have an ECOG performance status ≤ 2.\n8. Patient must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Castration-resistant prostate cancer (CRPC).\n2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy\n3. Spinal cord compression or impending spinal cord compression.\n4. Suspected pulmonary and/or liver metastases (greater \\>10 mm in largest axis).\n5. Patient receiving any other investigational agents.\n6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .\n7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.\n8. No radiographical evidence of cranial metastasis.\n9. Refusal to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT05223803', 'briefTitle': 'TERPS Trial for de Novo Oligometastic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial', 'orgStudyIdInfo': {'id': 'HP-00098826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Best systemic therapy (BST) + primary prostate radiation (XRT)', 'interventionNames': ['Radiation: Prostate radiation (XRT)', 'Drug: Systemic Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BST + XRT + SABR metastasis-directed therapy (MDT)', 'interventionNames': ['Radiation: Prostate radiation (XRT)', 'Drug: Systemic Therapy', 'Radiation: Stereotactic ablative radiation therapy (SABR)']}], 'interventions': [{'name': 'Prostate radiation (XRT)', 'type': 'RADIATION', 'description': 'Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.', 'armGroupLabels': ['BST + XRT + SABR metastasis-directed therapy (MDT)', 'Best systemic therapy (BST) + primary prostate radiation (XRT)']}, {'name': 'Systemic Therapy', 'type': 'DRUG', 'description': 'All systemic therapy is provided as best prescribed for patient per their medical oncologist.', 'armGroupLabels': ['BST + XRT + SABR metastasis-directed therapy (MDT)', 'Best systemic therapy (BST) + primary prostate radiation (XRT)']}, {'name': 'Stereotactic ablative radiation therapy (SABR)', 'type': 'RADIATION', 'description': 'SABR is delivered to those randomized to Arm 2.', 'armGroupLabels': ['BST + XRT + SABR metastasis-directed therapy (MDT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tyler Seibert, MD, PhD', 'role': 'CONTACT', 'email': 'tseibert@health.ucsd.edu', 'phone': '858-822-6040'}], 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Helie', 'role': 'CONTACT', 'email': 'nicole.helie@umm.edu', 'phone': '410-328-6304'}], 'facility': 'Maryland Proton Treatment Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Helie', 'role': 'CONTACT', 'email': 'nicole.helie@umm.edu', 'phone': '410-328-6304'}], 'facility': 'UMMC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21014', 'city': 'Bel Air', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lalicia Roman', 'role': 'CONTACT', 'email': 'lalicia.roman@umm.edu', 'phone': '443-643-1877'}], 'facility': 'Upper Chesapeake Health', 'geoPoint': {'lat': 39.53594, 'lon': -76.34829}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caitlin Eggleston', 'role': 'CONTACT', 'email': 'caitlineggleston@umm.edu', 'phone': '410-328-7586'}], 'facility': 'Central Maryland Radiation Oncology', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pilar Strycula, RN, BSN', 'role': 'CONTACT', 'email': 'Pstrycula@umm.edu', 'phone': '410-553-8110'}], 'facility': 'Baltimore Washington Medical Center', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessie DiNome, MD', 'role': 'CONTACT', 'email': 'Jessie.DiNome@jefferson.edu', 'phone': '215-955-8874'}], 'facility': 'Sidney Kimmel Cancer Center at Jefferson Health', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adam Olson, MD', 'role': 'CONTACT', 'email': 'olsonac2@upmc.edu', 'phone': '412-623-6720'}], 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '23114', 'city': 'Midlothian', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Pennington, MD', 'role': 'CONTACT', 'email': 'joseph_pennington@bshsi.org', 'phone': '804-266-7762'}], 'facility': 'Bon Secours Cancer Institute at St. Francis', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}], 'centralContacts': [{'name': 'Phuoc Tran, MD', 'role': 'CONTACT', 'email': 'Phuoc.Tran@umm.edu', 'phone': '410-369-5200'}, {'name': 'Nicole Helie', 'role': 'CONTACT', 'email': 'nicole.helie@umm.edu', 'phone': '410-328-6304'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Department of Radiation Oncology', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}