Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Sylmar, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeremie Calais
Headshot of Jeremie Calais
Jeremie Calais

Description

Summary

This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.

Official Title

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics

Details

OUTLINE:

Patients receive 177Lu-PSMA-617 intravenously (IV) over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA positron emission tomography/computed tomography (PET/CT) during screening and single photon emission computed tomography (SPECT)/CT on study. Patients also undergo CT or magnetic resonance imaging (MRI), bone scan, as well as blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 2 years.

Keywords

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Carcinoma, Prostatic Neoplasms, 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid, Pluvicto, Biospecimen Collection, Bone Scan, Computed Tomography, Lutetium Lu 177 Vipivotide Tetraxetan, Magnetic Resonance Imaging, PSMA PET-CT Scan, Single Photon Emission Computed Tomography

Eligibility

Locations

  • Olive View-University of California Los Angeles Medical Center not yet accepting patients
    Sylmar California 91342 United States
  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Fred Hutch/University of Washington Cancer Consortium accepting new patients
    Seattle Washington 98109 United States

Lead Scientist at UCLA

  • Jeremie Calais
    Nuclear medicine physician specialized in cancer imaging and theranostics. Associate Professor, Department of Molecular and Medical Pharmacology at UCLA Director, Theranostics Program, Ahmanson Translational Theranostics Division at UCLA Faculty Member of the Jonsson Comprehensive Cancer Center at UCLA. Faculty Member of the Institute of Urologic Oncology at UCLA.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT06526299
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 51 study participants
Last Updated