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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Undergo collection of urine samples
Undergo SPECT/CT
Given Ga-68 PSMA-11
Given IV
Undergo PET
Ancillary studies
Undergo SPECT/CT
Given IV
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
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.
Time frame: up to 6 weeks
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
Time frame: at 6 weeks after first dose and 12 weeks after last dose
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)
Time frame: Up to 30 weeks
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
Time frame: at 6 weeks after first dose and 12 weeks after last dose
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
Time frame: at 6 weeks after first dose and 12 weeks after last dose
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