Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis (RMPBX201801)

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.

Study Overview

• Status: Unknown
• Conditions: Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification; Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique; Establish the Efficacy Between the Four Schemes in Terms of the Patient's Subjective Perception Regarding Pain and Quality of Life; Establish the Association of the Tumor Biomarker in the Early Detection and Aggressiveness of Tumors; Establish the Possible Interaction Between Biomarkers and Resonance in Different Prostate Biopsy Models to Define Tumor Presence and / or Tumor Aggressiveness; Establish the Possible Relationship Between the Expression Profiles of the microRNAs; Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI
• Intervention / Treatment: Procedure: Multiparametric magnetic resonance

• Study Type: Observational
• Enrollment (Anticipated): 628

Contacts and Locations

• Study Contact: Name: Francisco Gomez Veiga; Phone Number: 55954 923291100; Email: fgveiga@telefonica.net

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Francisco Gómez Veiga
    • Contact: Francisco Gomez Veiga, Dr.; Email: fgveiga@telefonica.net
    • Sub-Investigator: Alvaro Virseda Rodríguez, Dr
    • Principal Investigator: Francisco Gómez Veiga, Dr.
    • Sub-Investigator: Manuel Herrero Polo, Dr.
    • Sub-Investigator: Manuela Martín Izquierdo, Dra.
    • Sub-Investigator: Alfredo Rodríguez Antolin, Dr
    • Sub-Investigator: Carmen Martín Hervas, Dra
    • Sub-Investigator: Dalia Rashid Salim
    • Sub-Investigator: Francisco Javier MartínVallejo
    • Sub-Investigator: Juan Alejandro Gomez Rivas, Dr.
    • Sub-Investigator: Francisco Javier Castell Monsalve, Dr.
    • Sub-Investigator: Juan José Fuertes Alija, Dr.
    • Sub-Investigator: Jose Heriberto Amon Sesmero, Dr
    • Sub-Investigator: Jesús Calleja Escudero, Dr.
    • Sub-Investigator: Maria José Buj Pradilla, Dra.
    • Sub-Investigator: Rafael Muñoz de Bustillo Llorente
    • Sub-Investigator: Coral Manso Aparicio, Dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients with suspected clinical risk of prostate cancer with total PSA values between 3 and 20 ng / mL, free PSA index / total PSA less than 20% and normal or abnormal rectal examination, candidates for a first prostate biopsy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiparametric magnetic resonance + transrectal biopsy; The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE)	Procedure: Multiparametric magnetic resonance; MRI uses a powerful magnetic field, pulsed radiofrequency and a computer to create detailed images of organs, soft tissues, bones, and practically the rest of the internal structures of the body. MRI does not use ionizing radiation (X-rays).; Other Names: Transrectal biopsy; Transperineal biopsy
Multiparametric magnetic resonance + transperineal biopsy; The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP)	Procedure: Multiparametric magnetic resonance; MRI uses a powerful magnetic field, pulsed radiofrequency and a computer to create detailed images of organs, soft tissues, bones, and practically the rest of the internal structures of the body. MRI does not use ionizing radiation (X-rays).; Other Names: Transrectal biopsy; Transperineal biopsy
Transrectal biopsy; The patient underwent a transrectal biopsy (BPTE)
Transperineal biopsy; The patient underwent a transperineal biopsy (BPTP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparation between transrectal and transperineal prostatic biopsy with o without Magnetic Resonance	Establish if there are differences between the transrectal and transperineal prostatic biopsy schemes in both cases with and without MRI, in patients with suspected clinical risk of prostate cancer (total PSA between 3 and 20 ng / mL, free PSA index / Total PSA less than 20% and normal or abnormal rectal examination) in terms of efficacy measured by the detection rate and tumor aggressiveness of the tumors detected, complication rates and cost analysis.	6 months

Collaborators and Investigators

• Sponsor: InvestigatorUrologyIBSAL
• Collaborators: Instituto de Investigación Biomédica de Salamanca

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; PSA; Prostate Cancer; Biomarkers; MMPm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Aggression; Prostatic Neoplasms
• Other Study ID Numbers: PI18/01560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No