Improving the Impact of Anti-Androgen Treatments on Patients' Daily Lives and Their Cancer (DE-ESCALATE)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Aarau, Basilea, Bellinzona, Chur, Ginevra, Losanna, Lugano, Luzern, Neuchâtel, San Gallo, Winterthur, Zurigo, Altro
(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)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Sheila Gaggetta
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
26.02.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
EORTC DE-ESCALATE Intermittent Androgen deprivation Therapy in the era of AR pathway inhibitors; a phase 3 pragmatic randomized trial (DE-ESCALATE) (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile