Study on PSMA [Lu-177]-PNT2002 Therapy for Treating Advanced Prostate Cancer After Hormonal Treatment

Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Sponsor score: 0

ClinicalTrials ID:NCT04647526

This clinical trial is testing a new treatment called [Lu-177]-PNT2002 for men with advanced prostate cancer that has spread and is not responding to hormonal therapy. The study aims to see if this treatment can safely and effectively slow down the progression of the cancer.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new treatment, [Lu-177]-PNT2002, in men with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to previous hormonal treatments. The study will compare this new treatment to existing medications, abiraterone or enzalutamide, to see which is better at delaying cancer progression.

Description

The study is divided into three parts:

Dosimetry Phase: This initial phase involves 25 patients to ensure the treatment is safe and to determine the correct dosage.
Randomized Treatment Phase: About 390 patients will be randomly assigned to receive either the new treatment [Lu-177]-PNT2002 or one of the standard treatments (abiraterone or enzalutamide). If the cancer progresses in patients receiving the standard treatment, they may switch to the new treatment if they meet certain criteria.
Long-term Follow-up Phase: After the main part of the study, all patients will be monitored for at least five years to track their overall survival and any long-term effects of the treatment.

To participate, patients must have prostate cancer that shows up on a specific type of scan (PSMA PET scan) and meet other health criteria.

Eligibility Criteria

Inclusion Criteria

Men aged 18 or older with confirmed prostate cancer.
Cancer must have progressed despite previous hormonal treatments.
Must have a specific type of prostate cancer that shows up on a PSMA PET scan.
Must have low testosterone levels and good organ function.
Must agree to use effective birth control methods if they have partners who are pregnant or could become pregnant.
Must be willing to start standard hormonal therapy if assigned to that treatment group.
Must be in good general health and able to follow study procedures.
Must provide informed consent to participate.

Exclusion Criteria

Prostate cancer with certain aggressive features or components.
Recent treatment for prostate cancer within 28 days before starting the study, except for specific allowed treatments.
Previous chemotherapy for advanced prostate cancer, except under certain conditions.
Previous treatment with certain radioactive or immunotherapy drugs.
More than one previous hormonal treatment that failed.
Active liver metastases larger than 1 cm.
Serious heart conditions or recent heart attacks.
Active infections or other serious health conditions that could interfere with the study.
Psychological or social issues that could affect participation.
Known brain metastases or spinal cord compression.

Locations

FACILITY	ZIP	CITY	STATE
Arizona Institute of Urology (AIU) - Tucson	85704	Tucson	Arizona
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	90048	Los Angeles	California
VA Greater Los Angeles Healthcare System	90073	Los Angeles	California
University of California Los Angeles, Nuclear Medicine Clinic	90095	Los Angeles	California
Hoag Memorial Hospital Presbyterian	92663	Newport Beach	California
UC Irvine Chao Family Comprehensive Cancer Center	92868	Orange	California
Stanford Cancer Institute	94305	Palo Alto	California
University of Colorado Hospital	80045	Aurora	Colorado
H. Lee Moffitt Cancer Center & Research Institute	33612	Tampa	Florida
University of Iowa Hospitals and Clinics	52242	Iowa City	Iowa

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