Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis

Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)

Objectives: To establish if there are differences between an ultrasound-guided transrectal prostate biopsy (BPTE) and a transperineal prostatic biopsy (BPTP) with and without a multiparametric Magnetic Resonance (RMmp) in patients with clinical suspicion of prostate cancer (PC) to first prostatic biopsy in terms of:

1. Rate of detection and diagnosis of prostate cancer.
2. Aggressiveness of the detected tumors.
3. Association of the marker [-2] proPSA and the prostate cancer health index (PHI) and microRNAs for the diagnosis of tumors.
4. Adverse effects of the intervention and subjective perception of the patient: pain and degree of satisfaction, and impairment of quality of life.
5. Cost-effectiveness analysis of the different intervention options.

Study Design: Randomized, single-blind prospective clinical study to compare four schemes: RMmp + BPTE vs. BPTE 12 cylinders vs RMmp + BPTP vs BPTP 12 cylinders.

Study population: Patients with clinical suspicion of prostate cancer with PSA between 3-20 ng / mL and normal or abnormal rectal examination, candidates for a first prostate biopsy.

Research techniques: BPTE standard of 12 cylinders compared to RMmp previous to BPTE vs BPTP of 12 cylinders compared to BPTP with previous RMmp.

Inclusion Criteria:

• Signature of informed consent prior to performing any of the specific procedures of the study
• Age between 50 * - 75 years (* 45 years, if family history)
• Patients with clinical suspicion of prostate cancer
• Indication of a first biopsy during the study period.
• Life expectancy greater than 10 years.

Exclusion Criteria:

• Patients previously randomized in the present study.
• Patients submitted prior to a prostate biopsy.
• Patients with a previous diagnosis of prostate cancer and / or previous prostate surgery.
• Patients with a previous episode of acute prostatitis of infectious origin in the 3 months prior to inclusion in the study.
• Patients with an active urinary tract infection and / or any previous pathology of severity in the 3 months prior to inclusion.
• Impossibility of performing transrectal or transperineal biopsy and / or magnetic resonance.
• Patients who have received hormonal treatment prior to androgen blockade in the 6 months prior to inclusion in the study.
• History of other tumors.