Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.
MEDCARE phase 3 trial is approved by the central Ethics committee. It is a multicentric, randomized, prospective, open-label, two-arm, phase III trial. The aim is to evaluate the impact of progression-directed therapy (PDT) in patients presenting with oligoprogressive mCRPC on overall survival (OS). The study will employ a 1:1 randomization between arm A and arm B. Patients will be stratified according to number of metastases (1 versus \> 1), initial localization (local recurrence, N or M1a vs. M1b or M1c) and systemic therapy (patient type 1 vs. type 2, see below) (Fig 1). Randomization will be carried out after approval in the multidisciplinary tumour board were the standard-of-care treatment and kind of PDT (metastasectomy or SBRT) will be decided before randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Progression-directed therapy (stereotactic body radiation therapy)
Progression-directed therapy (metastasectomy)
University Hospitals Leuven
Leuven, Belgium
RECRUITINGOverall Survival
Overall Survival
Time frame: will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.
Quality of life scoring EORTC QLQ-C30
Quality of life scoring using the EORTC QLQ-C30
Time frame: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24
Quality of life scoring EORTC QLQ-PR25
Quality of life scoring using the EORTC QLQ-PR25
Time frame: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24
Quality of life scoring EQ-5D-5L
Quality of life scoring using the EQ-5D-5L.
Time frame: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24
Cancer Specific Survival
Cancer Specific Survival
Time frame: will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.
Radiographic progression free survival
Radiographic progression free survival
Time frame: will be calculated from the day of randomisation until the first day of progression (local, nodal or metastatic). Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms, assessed up to 5 years.
Progression-directed therapy induced acute or late toxicity scoring
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Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity Criteria Version 5.0 and metastasectomy related toxicity will be scored using Clavien Dindo scoring system.
Time frame: Toxicity will be scored every follow-up visit, assessed up to 5 years after progression-directed therapy.