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NOT YET RECRUITING
NCT07682649
PHASE1

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

View on ClinicalTrials.gov

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

PROCEDURE

Biospecimen Collection

Undergo collection of urine samples

PROCEDURE

Computed Tomography

Undergo SPECT/CT

OTHER

Gallium Ga 68 Gozetotide

Given Ga-68 PSMA-11

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

DEVICE

Positron Emission Tomography

Undergo PET

OTHER

Questionnaire Administration

Ancillary studies

DEVICE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

OTHER

Technetium Tc-99m Sulfur Colloid

Given IV

Locations (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States