NCT06216249View on ClinicalTrials.gov

Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Prostate CarcinomaStage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Interventions
PROCEDURE

Computed Tomography

Undergo PSMA PET/CT, SPECT/CT, PET/CT and CT

OTHER

Gallium Ga 68 Gozetotide

Given IV

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

PSMA PET Scan

Undergo PSMA PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Trial Locations (1)

90095

RECRUITING

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles

Sponsors

Collaborators (1)

Novartis Pharmaceuticals
All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Jonsson Comprehensive Cancer Center

OTHER