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.
PRIMARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Undergo blood sample collection
Undergo rhPSMA-7.3 PET/CT and SPECT-CT
Undergo EBRT
Given IV
Given IV
Undergo rhPSMA-7.3 PET/CT
Undergo SPECT-CT scan
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Incidence of radiotherapy and radioligand therapy related adverse events
Will be summarized descriptively using frequencies and percentages of all captured toxicities by grade and relevance.
Time frame: Up to 6 weeks post last radioligand therapy dose
Tumor and organ at risk dosimetry
Descriptive statistics will be used to perform the post-hoc dosimetry for tumor as applicable and background organs after each cycle of radioligand therapy.
Time frame: At 1-3 days and 4-7 days post radioligand therapy
Circulating tumor deoxyribonucleic acid (ctDNA) differences
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.
Time frame: Up to 5 years
ctDNA differences
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.
Time frame: Up to 5 years
ctDNA differences
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.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.