Treatment of aggressive prostate cancers in real life: Initiation, schedule, and management of triptorelin treatment (TALISMAN)—Design of the study.

Abstract

TPS173 Background: Prostate cancer (PCa) treatment management mostly depends on tumor aggressiveness and patient frailty. Guidelines recommend an intensification of treatment in high risk PCa, with a longer duration of androgen deprivation therapy (ADT), and, for more advanced cases, an administration for life, on top of which additional treatments may be proposed. This implies a holistic management of the patient, including management of comorbidities and ADT side effects. Triptorelin is a widely used gonadotropin-releasing hormone agonist (GnRHa). Generating data on the use of triptorelin in real life will help physicians to analyze the parameters influencing the choice of the planned duration of treatment. Methods: This prospective, multicenter, non-interventional study is conducted in France. Patients are recruited by urologists, radiation oncologists and medical oncologists. Main inclusion criteria are a histologically confirmed PCa, eligible for triptorelin therapy in its label, with a planned total duration of triptorelin treatment of at least 12 months. Decision of triptorelin treatment is made before the inclusion in the study, in the routine practice. 3 visits are planned: V1 (baseline), V2 (at 6 months), V3 (at 12 months). Primary objective of the study is to describe the proportion of patients treated continuously with triptorelin during 12 months following treatment initiation. 786 patients are planned to be enrolled, this will allow to estimate the proportion of patients treated continuously with triptorelin during 12 months following treatment initiation for an expected proportion of 80% with a precision of 3 % taking into account a drop out rate of 15%. Main secondary objectives are to describe the planned total duration of triptorelin treatment and main reason of choice, to identify parameters (tumor aggressiveness criteria, patient frailty...) associated with this planned duration, to describe the formulation and route of administration of triptorelin and reasons of choice, to identify parameters associated with this choice, to describe the change from baseline in quality of life evaluated through QLQ-PR25 questionnaire, and to describe the safety of triptorelin in the real world setting. An interim analysis on baseline data will be performed once 50% of patients are enrolled. It will focus on planned total duration of triptorelin at initiation, main reasons of choice according to circumstances of prescription, formulation and route of administration, and their reasons of choice. Clinical trial information: NCT04593420.