Phase I/II Study of Stereotactic Ablative Reirradiation with Metformin for Relapse in Previously Irradiated Prostate Bed (REPAIR GETUG P16)

The primary objective of the study titled "RElapse in previously irradiated Prostate bed: a phase I/II study of stereotactic Ablative reIRradiation potentiated by Metformine (REPAIR GETUG P16)" is to evaluate the efficacy and safety of **stereotactic ablative reirradiation** in patients experiencing a relapse in the previously irradiated prostate bed. This study aims to determine the potential benefits of combining this treatment with Metformin, a medication commonly used in diabetes management, to enhance therapeutic outcomes. The clinical relevance of this study lies in its potential to offer a novel treatment approach for patients with recurrent prostate cancer, potentially improving local control and patient outcomes in a population with limited therapeutic options.

The clinical trial focuses on male participants experiencing a **relapse in previously irradiated prostate bed**. The study population comprises adult males, specifically those aged between 18 and 64 years. The trial does not include female subjects, and the participants are not considered part of a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The trial population was selected based on specific criteria, although these criteria have not been detailed by the sponsor.

The clinical trial is designed to evaluate the efficacy and safety of **stereotactic ablative reirradiation** potentiated by metformin in patients experiencing a relapse in a previously irradiated prostate bed. This study is structured as a phase I/II trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial commenced on November 26, 2020, and is projected to conclude by November 26, 2030, encompassing a total duration of approximately ten years.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to confirm eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits, the frequency and number of which are determined by the specific protocol requirements. These visits are essential for monitoring the participants' health status, assessing treatment efficacy, and identifying any adverse effects. The trial will culminate in an end-of-study visit, where final evaluations will be conducted to gather comprehensive data on the treatment outcomes.

The expected length of participant involvement in the study is contingent upon individual response to treatment and adherence to the study protocol. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study requirements, or withdraw consent. The trial's design and procedures are meticulously crafted to ensure the collection of robust data while prioritizing participant safety and well-being.

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 the administration of other medicinal products or their role in the trial.

Due to the lack of available data, specifics on dosing schedules, participant compliance monitoring, and any additional relevant information about drug administration cannot be described. The trial documentation does not include any product authorization status or information about the product's pharmaceutical form or active substances.

The clinical trial will assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on November 26, 2020, with an estimated completion date of November 26, 2030. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests that the trial may focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation.