Pharmacokinetics of Radium-223 Dichloride in Patients with Prostate Cancer Undergoing Radium-223 Treatment

The primary objective of this study is to evaluate the pharmacokinetics of **radium-223** in patients diagnosed with **prostate cancer** who are undergoing treatment with radium-223 dichloride. Understanding the movement and distribution of radium-223 within the body is clinically significant as it can inform dosing strategies and optimize therapeutic outcomes for patients with prostate cancer. This study does not list any secondary objectives.

The clinical trial involves a total of **9 participants** diagnosed with **prostate cancer**. The study population consists exclusively of male subjects, with an age range that includes both middle-aged and older adults. Participants were selected based on specific criteria, although detailed inclusion or exclusion criteria were not provided. The trial does not involve a vulnerable population, and no specific lifestyle considerations such as diet or physical activity were highlighted. The sponsor has not disclosed additional information regarding the general health status of the participants.

The clinical trial is designed to evaluate the pharmacokinetics of **radium-223** in patients diagnosed with **prostate cancer** who are undergoing treatment with radium-223 dichloride. This study is structured as a Phase 3, randomized, double-blind, controlled trial, ensuring the reliability and validity of the results. The trial commenced on June 1, 2020, and is projected to conclude by August 1, 2025, encompassing a comprehensive duration to adequately assess the treatment's effects.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This initial visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be randomized into treatment groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' response to the treatment, assess any adverse events, and ensure adherence to the study protocol. These visits are integral to collecting consistent data throughout the trial period.

The end-of-study visit marks the final assessment point, where comprehensive evaluations are conducted to gather final data on the treatment's efficacy and safety. The expected length of participant involvement spans the entire trial duration unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, withdrawal of consent, or any protocol deviations that compromise the study's integrity. The trial's design and procedures are meticulously crafted to uphold scientific rigor and ensure participant safety throughout the study period.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the experimental medication's **pharmaceutical form**, **dosage**, or **route of administration**. Furthermore, there is no information on whether the medication is a **paediatric formulation** or if it has an **orphan drug** designation.

As the source data does not provide any information on the **maximum daily dose**, **maximum total dose**, or **maximum treatment period**, these aspects cannot be addressed. Additionally, there is no information on any **other medicinal products** used in the study or the **product authorization status**. The **product dictionary information**, including the **name of the organization** and **substance origin**, is also not available.

The clinical trial is in Phase 3 and is scheduled to conclude by August 1, 2025. The recruitment for the trial began on June 1, 2020. The trial is categorized under trial category 1, with a specific trial category ID of 74246. The efficacy of the intervention will be assessed through parameters that are not explicitly detailed in the provided data. The trial's design and methodology for measuring, collecting, and analyzing efficacy parameters are not specified in the available information. The endpoints, tools, or instruments involved in the efficacy assessments are also not mentioned. The trial's primary and secondary endpoints, as well as the main objective, are not provided in the source data.