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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Washington
Study ID
NCT06526299
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (177Lu-PSMA-617)
    Patients receive 177Lu-PSMA-617 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-PET/CT during screening and SPECT/CT on study. Patients also undergo CT or MRI, bone scan, as well as blood sample collection throughout the study.

Primary Outcome Measure

Prostate-specific antigen (PSA) progression-free survival (PFS) [ Time Frame: From enrollment to PSA progression or death from any cause, assessed up to 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Thomas Hope (PRINCIPAL_INVESTIGATOR)
Olive View-University of California Los Angeles Medical CenterSylmarCalifornia91342
Jeremie Calais (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Akshata Mathur
[email protected]
206-667-5801
Amir Iravani, MD FRACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CAOlive View-University of California Los Angeles Medical Center· Sylmar, CAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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