Improving the Impact of Anti-Androgen Treatments on Patients' Daily Lives and Their Cancer (DE-ESCALATE)
Summary description of the study
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.
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Intervention under investigation
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.
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Disease under investigation
Metastatic Prostate Cancer
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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.
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Exclusion criteria
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.
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Trial sites
Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lugano, Luzern, Neuchatel, St. Gallen, Winterthur, Zurich, Other
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Davos, Frauenfeld, Grabs, Ilanz, Locarno, Mendrisio, Münsterlingen, Olten, Samedan, Thun, Thusis, Uznach, Walenstadt, Wil
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Sponsor
EORTC Brussels B Swiss Cancer Institute Bern CH
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Contact
Contact Person Switzerland
Sheila Gaggetta
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
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Scientific Information
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Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Ticino
(BASEC)
Date of authorisation
26.02.2026
(BASEC)
ICTRP Trial ID
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Official title (approved by ethics committee)
EORTC DE-ESCALATE Intermittent Androgen deprivation Therapy in the era of AR pathway inhibitors; a phase 3 pragmatic randomized trial (DE-ESCALATE) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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