Study protocol on quality of life and erectile function recovery in unfavorable intermediate-risk prostate cancer: REDI-CaP trial

Le résumé fourni par la source

In unfavorable intermediate-risk prostate cancer, radiotherapy plus androgen deprivation therapy (ADT) is standard, but GnRH agonists can cause testosterone flare and delayed hormonal recovery, negatively affecting erectile function (EF) and quality of life (QoL). Relugolix, an oral GnRH antagonist, enables rapid testosterone suppression and faster recovery after discontinuation. The REDI-CaP trial investigates whether combining Relugolix with high-precision stereotactic body radiotherapy (SBRT) aims to improve EF recovery while evaluating whether cancer control is maintained. REDI-CaP is a prospective, single-arm, single-center Phase II study enrolling 55 patients (accounting for an anticipated 10% attrition rate, to yield 50 evaluable patients for the primary analysis). Participants receive Relugolix 120 mg daily for 6 months (AIFA-approved off-label use). SBRT is delivered with the CyberKnife system (36.25 Gy in 5 fractions) during the fourth month of ADT. The primary endpoint is EF recovery 6 months after ADT cessation, defined as an IIEF-5 score >17 or an increase of ≥5 points from baseline. Secondary endpoints include biochemical progression-free survival, acute and late toxicity, and patient-reported outcomes. Approved by the Institutional Ethics Committee; conducted according to ICH-GCP and the Declaration of Helsinki. The REDI-CaP trial is designed to investigate whether integrating pharmacology with advanced radiotherapy can help preserve patients’ quality of life while assessing cancer control outcomes. Clinical Trial Registration: www.clinicaltrials.gov identifier is NCT07302451 and EU CT 2025-521170-33–00. Prostate cancer treatment often involves a combination of radiation therapy and hormone therapy (ADT). While effective, these treatments can cause side effects that significantly impact a man’s quality of life, most notably the loss of erectile function and a decrease in sexual well-being. The REDI-CaP study is a clinical trial designed to test a more precise treatment strategy. We are combining a modern, highly accurate form of radiotherapy called “CyberKnife SBRT” with a new type of oral hormone medication (Relugolix). Our goals are: To effectively treat the cancer using a shorter course of high-precision radiation. To see if using a hormone therapy that is cleared by the body more quickly, combined with radiation that avoids healthy tissues, is associated with faster and more complete recovery of their erectile function. In this study, patients will receive 6 months of the oral medication and 5 sessions of specialized radiotherapy. We will monitor their recovery through questionnaires and medical tests for 18 months. The study aims to evaluate whether this approach can successfully treat prostate cancer while exploring its potential to better protect the physical and emotional well-being of our patients.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.