The rationale of the PROCEDE trial is to explore a novel early detection strategy in which biopsy decision does not rely on one single MRI examination, but on the progression of the MRI lesion between 2 consecutive exams, with the objective of reducing the number of unnecessary biopsies, detection of non-clinically prostate cancer and, ultimately, overtreatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Patients randomized to the experimental arm will proceed with MRI surveillance. A follow-up visit is planned at 6 months with the result of a PSA test, and it is possible at each investigator's discretion, to prescribe the follow-up MRI at 6 months in case of rising PSA. Otherwise, the repeat MRI will be scheduled one year after the initial MRI. Images will also be sent to the coordinating center for central reviewing of the new MRI exam and assessment of progression.
university Hospital Grenoble
Grenoble, Grenoble, France
To evaluate the impact of a novel early detection strategy based on serial MRI
To evaluate the impact of a novel early detection strategy based on serial MRI exams, compared to the standard of care, on the rate of definitive treatment for localized prostate cancer
Time frame: at 2 years
To assess the impact of a new early-detection strategy based on repeated MRI
Time to the first event among (i) definitive treatment for localized prostate cancer, defined as one of the following procedures: radical prostatectomy, radiotherapy, brachytherapy, focal therapy; (ii) occurrence of prostate cancer metastases; (iii) all-cause death, occurring between randomization and 5-year follow-up.
Time frame: at 5 years.
To assess the impact of the new strategy on the number of prostate biopsies performed
Number of biopsy procedures performed.
Time frame: at 2 years and 5 years.
To assess changes in therapeutic options with the new strategy
Choice of definitive treatment, if applicable, among the following options: (i) brachytherapy, (ii) focal therapy, and (iii) unimodal therapy.
Time frame: at 2 years and 5 years.
To assess the oncologic safety with Adverse pathological criteria (pT3, pN1, detectable PSA)of the new strategy compared with the usual strategy
Adverse pathological criteria (pT3, pN1, detectable PSA) in patients treated with radical prostatectomy.
Time frame: at 2 years and 5 years.
To assess the oncologic outcomes (Biochemical recurrence-free survival, disease-specific survival and overall survival.of the new strategy compared with the usual strategy
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Biochemical recurrence-free survival, disease-specific survival (i.e., censoring non-disease-related deaths), and overall survival.
Time frame: at 2 years and 5 years.
To assess the impact of the new strategy on patients' anxiety levels and quality of life, evaluated at Day 0 and then annually for 5 years.
HADS scale, MAX-PC questionnaire, EPIC-26 questionnaire, EQ-5D-5L questionnaire. The combination of these questionnaires will allow us to assess the level of anxiety and the quality of life of patients treated with the new strategy; we have decided to use them together for a combined evaluation.
Time frame: at 5 years
To evaluate the cost-effectiveness of the new early-detection strategy compared with the standard of care from a societal perspective
ICUR. The incremental cost-utility ratio (ICUR) will be calculated by dividing the mean difference in costs by the mean difference in QALYs (estimated from the EQ-5D-5L). The ratio will be expressed as cost per healthy life-year gained.
Time frame: at 5 years.
To establish an MRI database enabling comparison of radiomic characteristics between patients who have progressed and those who have not, in order to identify new imaging features associated with disease progression.
Database collecting all MRI examinations in DICOM format, along with oncologic outcomes (progression/no progression).
Time frame: at 5 years