This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.
Patients must have mCRPC
Patients must have received at least one regimen of chemotherapy for mCRPC
Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
Patient with creatinine clearance < 50 mL/min
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo PET/CT and SPECT/CT
Gallium Ga 68 Gozetotide
Other interventionGiven IV
Lutetium Lu 177 Vipivotide Tetraxetan
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
12-month overall survival
12-month overall survival (OS) of patients with mCRPC who previously had a favorable response to a first regimen of 177Lu-PSMA-617 and are treated with re-challenge 177Lu-PSMA-617 therapy
Incidence of adverse events (AEs)
Overall and grade ≥ 3 AEs will be defined and graded according to Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to report the number and percentage of patients who experience AEs during re-challenge therapy. Separate statistics will be reported for grade ≥ 1 AEs and for grade ≥ 3 AEs. These descriptive statistics will be presented for the whole treatment as well as separately for each cycle. In addition, the relationship of AE to the study drug (related versus not related) will be reported. Results from laboratory test, physical examinations, and patient surveys will be used.
Rate of prostate specific antigen (PSA) response
Will be defined as a PSA decline of ≥ 50% during re-challenge therapy on two measurements ≥ 3 weeks apart. Descriptive statistics will be used to report the number and percentage of patients who had a PSA response to re-challenge therapy. The number and percentage of patients with any decrease in serum PSA level compared to the baseline PSA at time of study enrollment will be reported as well.
Biochemical progression-free survival (PFS)
Will be evaluated using Prostate Cancer Working Group 3 guidelines.
Overall Survival from start of first regimen
To determine OS from the start of the first regimen of 177Lu-PSMA-617 therapy (Cycle 1 Day 1) (each cycle is 6 weeks) through study completion.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Novartis Pharmaceuticals
Collaborator
