التفاصيل البيبلوغرافية
| العنوان: |
Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial. |
| المؤلفون: |
Berghen, Charlien, Joniau, Steven, Rans, Kato, Devos, Gaëtan, Poels, Kenneth, Slabbaert, Koen, Dumez, Herlinde, Albersen, Maarten, Goffin, Karolien, Haustermans, Karin, De Meerleer, Gert |
| المصدر: |
BMC Cancer; 5/24/2020, Vol. 20 Issue 1, p1-7, 7p, 1 Chart |
| مصطلحات موضوعية: |
CASTRATION-resistant prostate cancer, PROSTATE cancer, PATIENT selection, STEREOTAXIC techniques |
| مستخلص: |
Background: Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC) rely on a limited number of therapeutic agents resulting in a median survival of 2-3 years. A subgroup of those patients with mCRPC presents with oligoprogressive disease, with a limited number of progressive lesions while other metastases are still controlled by ongoing systemic treatment.Methods: In this single arm prospective phase II trial, we aim to include 18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions. Progression is based on conventional imaging, as the use of PSMA PET-CT is considered investigational. However all patients will undergo PSMA PET-CT and the images will be blinded until progression. Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT. Recruitment of patients for this trial started in January 2020 and will be completed approximately by December 2020.Discussion: In this phase 2 trial on oligoprogressive mCRPC, we will investigate the benefit of progression-directed therapy while continuing ongoing systemic treatment. We hypothesize that progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy for these oligoprogressive lesions will postpone the start of next-line systemic treatment and therefore serve as a new or add-on therapy in the spectrum of treatments available for mCRPC. The results of this trial will serve as guidance for a later randomized phase 3 trial. All participants are given an information sheet and are required to give written informed consent. Results will be published in a peer-reviewed journal.Trial Registration: This study is registered at ClinicalTrials.gov: NCT04222634 (December 18th 2019). [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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