This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.
Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake > liver uptake by visual assessment)
Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.)
Patients must be ≥18 years of age
Patients must have an ECOG performance status of 0 or 1
Does not meet criteria for standard Lu-177-PSMA-617 RLT
Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician
Prior RLT
Unmanageable concurrent bladder outflow obstruction or urinary incontinence
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of urine samples
Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Gallium Ga 68 Gozetotide
Other interventionGiven Ga-68 PSMA-11
Lutetium Lu 177 Vipivotide Tetraxetan
DrugGiven IV
Positron Emission Tomography
DeviceUndergo PET
Questionnaire Administration
Other interventionAncillary studies
Single Photon Emission Computed Tomography
DeviceUndergo SPECT/CT
Technetium Tc-99m Sulfur Colloid
Other interventionGiven IV
Dose limiting toxicity (DLT)
The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage.
Incidence of treatment related adverse events
Any treatment related adverse events of Grade 3 or higher (according to CTCAE v5.0) from time of cycle 1 administration until time of cycle 2 administration and from time of cycle 1 administration until 12 weeks after the last cycle administration
Completion of overall multi-cycle (4-5 cycles) planned treatment course
To determine the rate of successful completion of the complete planned treatment course (total of 4 or 5 cycles)
Biochemical (prostate-specific antigen [PSA]) response
Will be estimated as the proportion of patients with ≥ 50% drop in serum PSA levels from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
PSMA PET/CT response
Will be estimated as the proportion of patients with ≥ 30% drop in PSMA positive tumor volume on PET/CT from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
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University of Michigan Rogel Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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