Improving the Impact of Anti-Androgen Treatments on Patients' Daily Lives and Their Cancer (DE-ESCALATE)
Résumé de l'étude
There is a type of prostate cancer that responds to male hormones: testosterone and other androgens are produced by the body. These hormones promote cancer growth. The current cancer treatment aims to inhibit the production and effect of these hormones. For this reason, patients receive two medications. One prevents the production of testosterone in the body, while the other blocks the effect of androgens on cancer cells. This combination therapy is referred to as maximum androgen blockade. In current practice, it is continued without interruption until the disease progresses. However, the long-term continuous application of androgen blockade can impair quality of life and cause hot flashes, fatigue, as well as a reduction or loss of sexual function. Recent studies have shown that this treatment can be interrupted until the prostate-specific antigen (PSA) level rises again. This so-called intermittent therapy is associated with fewer side effects—without compromising survival rates. Therefore, the aim of this study is to demonstrate whether the combination of the two medications in maximum androgen blockade can be reduced—and whether this can improve the risk-benefit ratio of the treatment.
(BASEC)
Intervention étudiée
Comparison between continuous treatment and intermittent treatment: It is paused as long as the PSA level is 0.2 ng/ml or less and is resumed when the level exceeds this low threshold. Questionnaires will be used to assess how patients feel.
(BASEC)
Maladie en cours d'investigation
Metastatic Prostate Cancer
(BASEC)
Patients with metastatic prostate cancer who have already been treated with maximum androgen blockade for 6 to 12 months and have a PSA level of 0.2 ng/ml or less.
(BASEC)
Critères d'exclusion
Patients with metastatic prostate cancer in M1a stage for whom radiation therapy and a 2- to 3-year hormone therapy are planned. Patients who have undergone or will undergo bilateral orchiectomy, i.e., removal of both testicles. Patients who have previously or simultaneously been affected by another type of cancer whose natural course or treatment could affect the safety or efficacy assessment for this study.
(BASEC)
Lieu de l’étude
Aarau, Bâle, Bellinzona, Chur, Genève, Lausanne, Lugano, Luzern, Neuchâtel, St-Gall, Winterthur, Zurich, Autre
(BASEC)
Davos, Frauenfeld, Grabs, Ilanz, Locarno, Mendrisio, Münsterlingen, Olten, Samedan, Thun, Thusis, Uznach, Walenstadt, Wil
(BASEC)
Sponsor
EORTC Brussels B Swiss Cancer Institute Bern CH
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Sheila Gaggetta
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Tessin
(BASEC)
Date d'approbation du comité d'éthique
26.02.2026
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
EORTC DE-ESCALATE Intermittent Androgen deprivation Therapy in the era of AR pathway inhibitors; a phase 3 pragmatic randomized trial (DE-ESCALATE) (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible