Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients with Biochemically Recurrent Prostate Cancer
NCT ID: NCT06105918
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2023-11-29
2029-04-01
Brief Summary
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Detailed Description
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I. 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.
II. Analyze dosimetry of radioligand therapy (RLT) after each cycle of 177Lu-rhPSMA-10.1.
EXPLORATORY OBJECTIVE:
I. 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.
OUTLINE: This is a dose-escalation study of 177Lu-rhPSMA-10.1.
Patients 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.
Patients follow up 6 weeks after the last 177Lu-rhPSMA-10.1 administration.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (EBRT, 177Lu-rhPSMA-10.1)
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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo rhPSMA-7.3 PET/CT and SPECT-CT
External Beam Radiation Therapy
Undergo EBRT
Flotufolastat F-18
Given IV
Lutetium Lu 177 PSMA-10.1
Given IV
Positron Emission Tomography
Undergo rhPSMA-7.3 PET/CT
Single Photon Emission Computed Tomography
Undergo SPECT-CT scan
Interventions
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Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo rhPSMA-7.3 PET/CT and SPECT-CT
External Beam Radiation Therapy
Undergo EBRT
Flotufolastat F-18
Given IV
Lutetium Lu 177 PSMA-10.1
Given IV
Positron Emission Tomography
Undergo rhPSMA-7.3 PET/CT
Single Photon Emission Computed Tomography
Undergo SPECT-CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
* Age over 18
Exclusion Criteria
* Risk factors for Lu-rhPSMA radioligand therapy (Baseline \>= grade 2 myelosuppression, renal insufficiency \[glomerular filtration rate (GFR) \< 60 mL/min\], or xerostomia)
* Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)
* Unacceptable medical or radiation safety risk
* Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention
* GFR \< 60 mL/min or creatinine \> 1.5-fold upper limit of normal (ULN)
* Liver enzymes \> 5-fold ULN
* Total white cell count less than 2.5 x 10\^9 /L
* Platelet count less than 75 x 10\^9 /L
* Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity, xerostomia, or gastrointestinal (GI) toxicity
* Severe acute co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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David M Schuster
Principal Investigator
Principal Investigators
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David M Schuster, MD, FACR
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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David M. Schuster, MD, FACR
Role: primary
Bridget Fielder, RN
Role: backup
David M. Schuster, MD, FACR
Role: backup
References
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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.
Other Identifiers
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NCI-2023-03480
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00005677
Identifier Type: OTHER
Identifier Source: secondary_id
RAD5633-23
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00005677
Identifier Type: -
Identifier Source: org_study_id