Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06105918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'C000615061', 'term': 'Lutetium-177'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D017785', 'term': 'Photons'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of radiotherapy and radioligand therapy related adverse events', 'timeFrame': 'Up to 6 weeks post last radioligand therapy dose', 'description': 'Will be summarized descriptively using frequencies and percentages of all captured toxicities by grade and relevance.'}], 'secondaryOutcomes': [{'measure': 'Tumor and organ at risk dosimetry', 'timeFrame': 'At 1-3 days and 4-7 days post radioligand therapy', 'description': 'Descriptive statistics will be used to perform the post-hoc dosimetry for tumor as applicable and background organs after each cycle of radioligand therapy.'}, {'measure': 'Circulating tumor deoxyribonucleic acid (ctDNA) differences', 'timeFrame': 'Up to 5 years', 'description': 'Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize baseline ctDNA and post-radiotherapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.'}, {'measure': 'ctDNA differences', 'timeFrame': 'Up to 5 years', 'description': 'Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize post radiotherapy ctDNA and post-radioligand therapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.'}, {'measure': 'ctDNA differences', 'timeFrame': 'Up to 5 years', 'description': 'Descriptive statistics (number of subject, mean, median, standard deviation, minimum, and maximum) will be used to summarize baseline ctDNA and post-radioligand therapy ctDNA. Wilcoxon Signed-Ranks Test or paired samples t-test will be used to perform comparisons.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biochemically Recurrent Prostate Carcinoma', 'Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38407630', 'type': 'DERIVED', 'citation': "Wurzer A, De Rose F, Fischer S, Schwaiger M, Weber W, Nekolla S, Wester HJ, Eiber M, D'Alessandria C. Preclinical comparison of [177Lu]Lu-rhPSMA-10.1 and [177Lu]Lu-rhPSMA-10.2 for endoradiotherapy of prostate cancer: biodistribution and dosimetry studies. EJNMMI Radiopharm Chem. 2024 Feb 26;9(1):18. doi: 10.1186/s41181-024-00246-2."}]}, 'descriptionModule': {'briefSummary': 'This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \\[177Lu-rhPSMA-10.1\\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Demonstrate the safety and feasibility of treating radiotherapy (RT) prostate cancer patients via addition of lutetium Lu 177 PSMA-10.1 (177Lu-rhPSMA-10.1) in a selected post-prostatectomy population.\n\nII. Analyze dosimetry of radioligand therapy (RLT) after each cycle of 177Lu-rhPSMA-10.1.\n\nEXPLORATORY OBJECTIVE:\n\nI. Determine the feasibility of and develop preliminary data in the correlation of circulating tumor circulating tumor deoxyribonucleic acid (ctDNA) at baseline, after RT, and RLT.\n\nOUTLINE: This is a dose-escalation study of 177Lu-rhPSMA-10.1.\n\nPatients undergo external beam radiation therapy (EBRT) followed by 177Lu-rhPSMA-10.1 intravenously (IV) on study. Patients also receive flotufolastat F-18 (rhPSMA-7.3) IV with positron emission tomography (PET)/computed tomography (CT) at screening and undergo single-photon emission computed tomography (SPECT)-CT and collection of blood samples on study.\n\nPatients follow up 6 weeks after the last 177Lu-rhPSMA-10.1 administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)\n* Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)\n* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2\n* Age over 18\n\nExclusion Criteria:\n\n* Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)\n* Risk factors for Lu-rhPSMA radioligand therapy (Baseline \\>= grade 2 myelosuppression, renal insufficiency \\[glomerular filtration rate (GFR) \\< 60 mL/min\\], or xerostomia)\n* Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)\n* Unacceptable medical or radiation safety risk\n* Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention\n* GFR \\< 60 mL/min or creatinine \\> 1.5-fold upper limit of normal (ULN)\n* Liver enzymes \\> 5-fold ULN\n* Total white cell count less than 2.5 x 10\\^9 /L\n* Platelet count less than 75 x 10\\^9 /L\n* Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity, xerostomia, or gastrointestinal (GI) toxicity\n* Severe acute co-morbidity, defined as follows:\n\n * Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months\n * Transmural myocardial infarction within the last 6 months\n * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients'}, 'identificationModule': {'nctId': 'NCT06105918', 'briefTitle': 'Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy', 'orgStudyIdInfo': {'id': 'STUDY00005677'}, 'secondaryIdInfos': [{'id': 'NCI-2023-03480', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00005677', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'RAD5633-23', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (EBRT, 177Lu-rhPSMA-10.1)', 'description': 'Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Radiation: External Beam Radiation Therapy', 'Other: Flotufolastat F-18', 'Drug: Lutetium Lu 177 PSMA-10.1', 'Procedure: Positron Emission Tomography', 'Procedure: Single Photon Emission Computed Tomography']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo rhPSMA-7.3 PET/CT and SPECT-CT', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiation', 'External Beam Radiotherapy', 'External Beam Radiotherapy (conventional)', 'External Beam RT', 'external radiation', 'External Radiation Therapy', 'external-beam radiation', 'Radiation, External Beam', 'Teleradiotherapy', 'Teletherapy', 'Teletherapy Radiation'], 'description': 'Undergo EBRT', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'Flotufolastat F-18', 'type': 'OTHER', 'otherNames': ['(18F)-rhPSMA-7.3', '18F-rhPSMA-7.3', '18FrhPSMA-7.3', 'F-18-rhPSMA-7.3', 'Fluorine F 18 radiohybrid PSMA-7.3', 'Fluorine F 18 rhPSMA-7.3', 'Fluorine-18 rhPSMA-7.3', 'rhPSMA-7.3 (18F)'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'Lutetium Lu 177 PSMA-10.1', 'type': 'DRUG', 'otherNames': ['(177Lu) rhPSMA-10.1', '177Lu Radiohybrid PSMA-10.1', '177Lu rhPSMA-10.1', '177Lu-rhPSMA-10.1'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging', 'PT'], 'description': 'Undergo rhPSMA-7.3 PET/CT', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}, {'name': 'Single Photon Emission Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Single Photon Emission Computed Tomography', 'Single Photon Emission Tomography', 'Single-Photon Emission Computed', 'single-photon emission computed tomography', 'SPECT', 'SPECT imaging', 'SPECT SCAN', 'SPET', 'ST', 'tomography, emission computed, single photon', 'Tomography, Emission-Computed, Single-Photon'], 'description': 'Undergo SPECT-CT scan', 'armGroupLabels': ['Treatment (EBRT, 177Lu-rhPSMA-10.1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'David M Schuster, MD, FACR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Hospital/Winship Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David M Schuster', 'investigatorAffiliation': 'Emory University'}}}}