TEMPORARILY_NOT_AVAILABLENot Applicable

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

United States

Plain-language 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

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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;

Exclusion criteria

Trial details

NCT IDNCT06033001

SponsorLantheus Medical Imaging

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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