Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 2:48 AM
Study NCT ID:
NCT06044857
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2023-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PSMA PET Response Guided SabR in High Risk Pca
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718244', 'term': 'gallium 68 PSMA-11'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Target Intra-Prostatic Lesion(s)', 'timeFrame': 'Through end of neoadjuvant ADT at 3 months', 'description': 'This study primarily evaluates volume reduction of initial target PSMA-avid dominant intra-prostatic disease after neoadjuvant ADT and during SAbR in differing spacing regimens of SAbR.\n\nMetrics include percent reduction in volume at 3 months of therapy vs initial disease extent of intra-prostatic dominant lesion as identified by PSMA PET.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Sequential cohort evaluation of ideal timing of imaging and treatment spacing to discern maximal PSMA (Prostate specific membrane antigen) PET (Positron Emission Tomography) response (PSMA-11 68Ga, Illucix) for adaptation of dominant intra-prostatic lesion tumor boost dose'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Pathologically confirmed adenocarcinoma of the prostate (within 180 days of registration) of high risk by national comprehensive cancer network (NCCN) criteria as determined by \\>=cT3a stage (AJCC 8th edition) OR PSA\\>20ng/mL OR ISUP Grade Group 4-5 (Gleason Grade 8-10).\n\nAge ≥ 18 years.\n\n* Planned for definitive intent stereotactic ablative radiotherapy (SabR) with integrated dose boost to intra-prostatic tumor and androgen deprivation therapy (ADT) with baseline AUA IPSS \\<=18 and prostate size \\<=100cc\n* Staging 68Ga PMSA-11 PET -CT or -MRI performed within 90 days of registration and before initiation of anti-androgen or androgen deprivation therapy and demonstrating no evidence of distant metastases by (PMSA avid or non-avid nodes \\<=1.5cm short axis allowed). Conventional imaging (CT, bone scan, MRI) may also be used in addition to PMSA-PET, and definitive findings of distant extra-pelvic metastases on these scans are not allowed for enrollment.\n* Staging 68Ga PSMA-11 PET -CT or -MRI demonstrating a PSMA-avid primary intra-prostatic target lesion amenable at investigator discretion to dose boost\n* All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SabR and for a period of time of 6 months thereafter as per standard guidelines. Should a man's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior curative intent local therapy (e.g. prostatectomy, radiotherapy, focal ablative therapy) for prostate cancer is not allowed, with following exceptions regarding androgen deprivation therapy (ADT)/anti-androgen therapy (AAT):\n\nPrior androgen deprivation therapy (ADT) allowed if \\<3 month total duration and stopped \\>=3 months prior to registration with demonstration of non-castrate testosterone recovery (\\>50ng/dL) and meeting all other inclusion criteria.\n\nOngoing androgen deprivation therapy (ADT) is allowed if \\<=60 days total duration AND meeting following criteria:\n\nIf GnRH agonist used (e.g. leuprolide), bicalutamide must have been used for at least 30 days +/-14 days from start of GnRH agonist.\n\nAll other inclusion criteria.\n\n* Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.\n* History of allergic reactions to PMSA-11 68Ga imaging agent.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.\n* Prior pelvic radiotherapy other than cutaneous/superficial treatments."}, 'identificationModule': {'nctId': 'NCT06044857', 'briefTitle': 'PSMA PET Response Guided SabR in High Risk Pca', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Phase IB Study of Personalized Ultrahypofractionated Stereotactic Ablative Radiotherapy of High Risk PROstate Cancer Guided by PET PSMA (68Ga PMSA-11; Ilucix) Response (PULSAR ProPhet)', 'orgStudyIdInfo': {'id': 'STU-2023-0566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAbR Every other day', 'description': 'SAbR given 2-3/week, at least every other day in spacing with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.', 'interventionNames': ['Drug: 68-Ga PSMA11']}, {'type': 'EXPERIMENTAL', 'label': 'PULSAR every week', 'description': 'SAbR given 1/week, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.', 'interventionNames': ['Drug: 68-Ga PSMA11']}, {'type': 'EXPERIMENTAL', 'label': 'PULSAR every 2 weeks', 'description': 'SAbR given every 2 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.', 'interventionNames': ['Drug: 68-Ga PSMA11']}, {'type': 'EXPERIMENTAL', 'label': 'PULSAR every 3 weeks', 'description': 'SAbR given every 3 weeks, with long-term ADT (neoadjuvant ADT x 3months required) with experimental Illucix (PSMA-11 68Ga) PET before and during SAbR (between fraction 3 and 4) to assess and adapt to dominant intra-prostatic lesion boost dose.', 'interventionNames': ['Drug: 68-Ga PSMA11']}], 'interventions': [{'name': '68-Ga PSMA11', 'type': 'DRUG', 'otherNames': ['Illucix, Telix'], 'description': 'Will be injected/assessed in line with its FDA label.', 'armGroupLabels': ['PULSAR every 2 weeks', 'PULSAR every 3 weeks', 'PULSAR every week', 'SAbR Every other day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75239', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Neufeld', 'role': 'CONTACT', 'email': 'Sarah.Neufeld@utsouthwestern.edu', 'phone': '214-648-1836'}, {'name': 'Liliana Robles', 'role': 'CONTACT', 'email': 'Liliana.Robles@utsouthwestern.edu', 'phone': '214-648-1836'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Sarah Neufeld', 'role': 'CONTACT', 'email': 'Sarah.hardee@utsouthwestern.edu', 'phone': '214-645-8525'}, {'name': 'Liliana Robles', 'role': 'CONTACT', 'email': 'liliana.robles@utsouthwestern.edu', 'phone': '214-645-8525'}], 'overallOfficials': [{'name': 'Neil Desai, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Once Upon a Time Foundation', 'class': 'OTHER'}, {'name': 'Telix Pharmaceuticals (Innovations) Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Neil Desai', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}