Evaluation of the Biological Effects of Saruparib (AZD5305) and Darolutamide, Alone and in Combination, in Patients with Newly Diagnosed Prostate Cancer Undergoing Radical Prostatectomy

The primary objective of this clinical trial is to evaluate the **biological effects** of Saruparib (AZD5305) alone, Darolutamide alone, and their combination in patients with newly diagnosed **prostate cancer** who are scheduled to undergo radical prostatectomy. Understanding the biological effects of these treatments is clinically relevant as it may inform therapeutic strategies and improve outcomes for patients with prostate cancer. No secondary objectives are provided for this study.

The clinical trial involves a total of **80 participants** who have been newly diagnosed with **prostate cancer**. The study population consists exclusively of male subjects, as indicated by the trial's focus on a condition affecting the male reproductive system. Participants fall within the age range of 18 to 64 years, encompassing both young adults and middle-aged individuals. The selection process for the trial population did not target any vulnerable groups, ensuring a focus on a general male demographic. While specific lifestyle considerations such as diet, physical activity, or habits are not detailed, the trial does not include female subjects, aligning with the condition under investigation. The sponsor has not provided information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is designed to evaluate the **biological effects** of Saruparib (AZD5305) alone, Darolutamide alone, and in combination in patients with newly diagnosed **prostate cancer** who are scheduled to undergo radical prostatectomy. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is August 4, 2023, with an anticipated end date of November 14, 2025. The trial will involve multiple study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will be randomly assigned to one of the treatment groups and will receive the study medication according to the trial protocol.

Throughout the trial, participants will attend regular follow-up visits to monitor their health status, assess treatment efficacy, and record any adverse events. These visits are crucial for ensuring participant safety and for collecting data necessary for the trial's endpoints. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes of the interventions. The expected length of participant involvement will vary depending on individual response to treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial aims to provide valuable insights into the treatment of newly diagnosed prostate cancer, contributing to the advancement of therapeutic strategies in this field.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 4, 2023, with an estimated completion date of November 14, 2025. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger patient population. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy outcomes.