NCT06526299 · University of Washington
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease
What this study 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).
View original scientific description
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).
Interventions
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
Primary outcome measures
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
PSA progression is defined as a rise in PSA at \> 12 weeks by more than 25% and more than 2ng/mL above the nadir (lowest PSA point). Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have the ability to understand and sign an approved informed consent.
- Patients must have the ability to understand and comply with all protocol requirements.
- Patients must be ≥ 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients must have a life expectancy \> 6 months.
- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
- Patients must have a positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion, as determined by the Nuclear Medicine site investigator. The presence of PSMA-positive lesions was defined as 68Ga-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. PSMA negative disease defined as lymph nodes of 2.5 cm or visceral lesions or soft tissue component of a lytic bone lesion of 1.0 cm or larger with uptake less than that of liver parenchyma.
Where
- San Francisco, California
- Sylmar, California
- Seattle, Washington
Collaborators
Novartis, Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations