Actively Recruiting

Phase 2
Age: 18Years +
MALE
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

Led by University of Washington · Updated on 2026-03-24

51

Participants Needed

3

Research Sites

139 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

Novartis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and sign informed consent
  • Ability to comply with study requirements
  • Male patients aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy greater than 6 months
  • Confirmed prostate cancer by histology, pathology, or cytology
  • Positive 68Ga-PSMA PET/CT scan without PSMA-negative lesions
  • Whole body tumor SUVmean less than 10 on 68Ga-PSMA PET/CT scan
  • Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum testosterone levels
  • Received at least one androgen receptor pathway inhibitor (ARPI)
  • Progressive metastatic castration-resistant prostate cancer documented by PSA progression, soft-tissue progression, or bone disease progression
  • At least one metastatic lesion visible on recent imaging within 45 days prior to treatment
  • Recovery to grade 2 or less from prior therapy toxicities
  • Adequate blood counts and organ function including WBC, ANC, platelets, hemoglobin, bilirubin, liver enzymes, albumin, and creatinine
  • HIV-infected patients on effective therapy with undetectable viral load are eligible
  • Use of acceptable birth control methods during and for 14 weeks after treatment
  • For patients with hepatitis B or C, viral load must be undetectable or patient cured
Not Eligible

You will not qualify if you...

  • Previous treatment with certain radionuclides or hemi-body irradiation within 6 months
  • Prior PSMA-targeted radioligand therapy
  • Any systemic anti-cancer therapy within 30 days before treatment
  • Use of investigational agents within 30 days before treatment
  • Known allergy to study therapy components
  • Concurrent cytotoxic chemotherapy, immunotherapy, or investigational therapy
  • Blood transfusion within 30 days before treatment
  • Untreated or unstable central nervous system metastases
  • Symptomatic or impending spinal cord compression
  • Serious concurrent medical conditions that impair participation such as advanced heart failure, uncontrolled infections, or active hepatitis B or C not controlled

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

2

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States, 91342

Not Yet Recruiting

3

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

A

Akshata Mathur

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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