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

NCT06033001 | Unknown

• 1 other identifier: LNTH-PNT2002-EAP01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Castration-Resistant Prostatic Cancer

Keywords

progressive mCRPC

Interventions

[Lu-177]-PNT2002 DRUG

\[Lu-177\]-PNT2002, is a radiopharmaceutical investigational drug. \[Lu-177\]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. \[Lu-177\]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. \[Lu-177\]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male aged 18 years or older;
• Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate;
• Patients must have at least 1 metastatic lesion present on CT, MRI, or bone scan imaging;
• Patients must have progressive mCRPC based on at least 1 of the following criteria:
• 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
• 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
• Progression of bone disease defined as the appearance of 2 or more lesions by bone scan
• Progression on prior treatment with ≥1 ARPI (abiraterone, apalutamide, darolutamide, enzalutamide ) in nmCRPC, mHSPC or mCRPC;
• PSMA-PET scan (\[Ga-68\]-PSMA-11 or \[F-18\]-DCFPyL) positive as determined by local investigator;
• At least 1 PSMA-PET positive lesion for prostate cancer
• Uptake greater than the liver will be used as the reference for determining PSMA-PET positivity and uptake less than or equal to the liver will be used as the reference for determining PSMA-PET negativity
• All lymph nodes that measure ≥25 mm in short axis on anatomic imaging must be PSMA-PET positive
• All bone metastases with soft tissue component(s) ≥10 mm in short axis must be PSMA-PET positive (PSMA-negative osseous metastases without a soft tissue component do not exclude patients)
• All solid organ metastases (i.e., lung, liver, adrenal glands, etc.) ≥10 mm in short axis must be PSMA-PET positive
• Castrate levels of circulating testosterone (\<1.7 nmol/L or \<50 ng/dL);

You may not qualify if:

• Prior PSMA-targeted radioligand therapy (i.e., \[Lu-177\]-PSMA-617);
• 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;
• 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;
• Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history or CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast);
• Symptomatic cord compression, or clinical radiologic findings indicative of impending cord compression;
• Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions such as ureteral obstruction, which in the opinion of the investigator would compromise safe participation in the \[Lu-177\]-PNT2002 EAP;
• Not able to understand and comply with treatment instructions and requirements;

Sponsors & Collaborators

• Lantheus Medical Imaging: lead
• Eli Lilly and Company: collaborator

Study Sites (7)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Hartford HealthCare Cancer Institute at Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Florida Theranostics Cancer Center

Jupiter, Florida, 33458, United States

Location

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

Location

Comprehensive Hematology Oncology

Trinity, Florida, 34655, United States

Location

BAMF Health, Inc

Grand Rapids, Michigan, 49503, United States

Location

John Theurer Cancer Center at Hackensack Meridian University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 13, 2023
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (7)