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Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer
Sponsor: University of Michigan Rogel Cancer Center
Summary
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.
Official title: A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12-01
Completion Date
2031-12
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Biospecimen Collection
Undergo collection of urine samples
Computed Tomography
Undergo SPECT/CT
Gallium Ga 68 Gozetotide
Given Ga-68 PSMA-11
Lutetium Lu 177 Vipivotide Tetraxetan
Given IV
Positron Emission Tomography
Undergo PET
Questionnaire Administration
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Technetium Tc-99m Sulfur Colloid
Given IV
Locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States