NCT06526299

Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Metastatic Castration-Resistant Prostate Carcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Computed Tomography	Undergo SPECT/CT and CT
DRUG	Lutetium Lu 177 Vipivotide Tetraxetan	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	PSMA PET-CT Scan	Undergo PSMA PET/CT
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Single Photon Emission Computed Tomography	Undergo SPECT/CT

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-07-29
• Last updated: 2026-03-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study