Phase 0 Study on Biodistribution and PET Imaging Kinetics of [64Cu]Cu-PSMA-R2 in Patients with Metastatic Prostate Cancer

The primary objective of this exploratory, Phase 0 study is to assess the **biodistribution** and **positron emission tomography (PET) imaging kinetics** of [64Cu]Cu-PSMA-R2 in patients with **metastatic prostate cancer**. This evaluation is clinically relevant as it aims to enhance the understanding of the distribution and imaging characteristics of the radiotracer, which could potentially inform future diagnostic and therapeutic strategies for this patient population.

The clinical trial focuses on **metastatic prostate cancer** and involves a study population exclusively comprising male subjects. The age range of participants falls within categories 3 and 4, indicating an adult population. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. The trial does not include female subjects, and no significant inclusion or exclusion criteria have been highlighted by the sponsor.

The clinical trial is designed as a **randomized**, double-blind, controlled study to evaluate the biodistribution and imaging kinetics of [64Cu]Cu-PSMA-R2 in patients with **metastatic prostate cancer**. The trial is categorized as a Phase 3 study, with an estimated recruitment start date of October 1, 2024, and an anticipated completion date of December 31, 2025. The trial will involve a series of structured visits, beginning with an inclusion visit, where participants will undergo screening to determine eligibility based on predefined criteria. This visit will include assessments such as medical history review, physical examination, and necessary laboratory tests.

Following the inclusion visit, participants will be scheduled for multiple follow-up visits throughout the study duration. These visits are intended to monitor the participants' health status, assess the biodistribution of the investigational product, and collect imaging data using **Positron Emission Tomography (PET)**. The sequence and frequency of these visits will be determined by the study protocol, ensuring comprehensive data collection and participant safety. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes and any potential adverse effects.

The expected length of participant involvement will be aligned with the trial's duration, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent by the participant, or any protocol deviations that compromise the integrity of the study. The trial's methodology and design are structured to ensure rigorous data collection and analysis, contributing to the understanding of the investigational product's efficacy and safety in the target patient population.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 1, 2024, with an estimated completion date of December 31, 2025. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The data collection and analysis will adhere to rigorous standards typical of Phase 3 trials, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory requirements and scientific best practices to evaluate the therapeutic benefits of the investigational product.