Clinical Trial · 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

Overview

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.

Sponsor

University of Washington

Phase

Phase 2

Contacts

Akshata Mathur (CONTACT)

nucmedresearch@fredhutch.org

206-667-5801

Angela Castellanos Rodriguez, MD, MSc (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06526299

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Working Group 3 (PCWG3) criteria, Scher et al 2016).
Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 45 days prior to beginning study therapy. Measurable disease by per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 is not required, as prostate cancer patients may not have RECIST-measurable disease but have detectable disease on bone scan.
Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (such as enzalutamide and/or abiraterone).
Albumin \> 3.0 g/dL (3.0 g/dL is equivalent to 30 g/L).
White blood cell (WBC) count ≥ 2.5 x 10\^9/L (2.5 x 10\^9/L is equivalent to 2.5 x 10\^3/uL and 2.5 x K/uL and 2.5 x 10\^3/cumm and 2500/uL) OR absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1.5 x 10\^9/L is equivalent to 1.5 x 10\^3/uL and 1.5 x K/uL and 1.5 x 10\^3/cumm and 1500/uL).
Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
Hemoglobin ≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L).
Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
Platelets ≥ 100 x 10\^9/L (100 x 10\^9/L is equivalent to 100 x 10\^3/uL and 100 x K/uL and 100 x 10\^3/cumm and 100,000/uL).
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.
Patients must have whole body tumor SUVmean of \< 10 on 68Ga-PSMA PET/CT scan, as determined by the Nuclear Medicine site investigator. 68GaPSMA PET/CT will be analyzed using a semi-quantitative approach with MIM software (MIM Software Inc.). The workflow identified whole-body regions of interest (ROIs) with an maximum standardized uptake value (SUVmax) greater than 3 and a lesion size of at least 0.5 mm. The reviewer then manually removes any instances of physiological activity or uptake that are not related to the disease. The method of whole-body quantification will automatically calculate the whole body SUVmean.

Exclusion

Exclusion criteria not yet provided.