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Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Clinical Trials | Clareo Health

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Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06033001•Lantheus Medical Imaging

View on ClinicalTrials.gov

Summary

The purpose of this program is to provide access to \[Lu-177\]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials. In this program participants will be administered \[Lu-177\]-PNT2002 intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment, participants will be monitored with routine laboratory tests such as: * Hematology blood tests * Clinical Chemistry blood tests * Testosterone/Prostate Antigen levels blood test * Vital signs * Imaging * ECG

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Patient is male aged 18 years or older;
•2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate;
•3. Patients must have at least 1 metastatic lesion present on CT, MRI, or bone scan imaging;
•4. Patients must have progressive mCRPC based on at least 1 of the following criteria:
•1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and \>2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart
•2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameters (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion
•3. Progression of bone disease defined as the appearance of 2 or more lesions by bone scan
•5. Progression on prior treatment with ≥1 ARPI (abiraterone, apalutamide, darolutamide, enzalutamide ) in nmCRPC, mHSPC or mCRPC;
•6. PSMA-PET scan (\[Ga-68\]-PSMA-11 or \[F-18\]-DCFPyL) positive as determined by local investigator;
•1. At least 1 PSMA-PET positive lesion for prostate cancer
+21 more criteria

Exclusion Criteria

•1. Prior PSMA-targeted radioligand therapy (i.e., \[Lu-177\]-PSMA-617);
•2. A superscan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity;
•3. Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity;

Locations (7)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Hartford HealthCare Cancer Institute at Hartford Hospital

Hartford, Connecticut, United States

Florida Theranostics Cancer Center

Jupiter, Florida, United States

Biogenix Molecular, LLC

Miami, Florida, United States

Comprehensive Hematology Oncology

Trinity, Florida, United States

BAMF Health, Inc

Grand Rapids, Michigan, United States

John Theurer Cancer Center at Hackensack Meridian University Medical Center

Hackensack, New Jersey, United States

Key Dates

Last Updated

January 13, 2025

Conditions

Castration-Resistant Prostatic Cancer

Interventions

[Lu-177]-PNT2002

DRUG

The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

NCT04104607

Castration-Resistant Prostatic Cancer

View study

TERMINATEDPHASE1

A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).

NCT04404140

Castration-Resistant Prostatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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