NCT04283032: RMPBX201801

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

Status unknown Last updated 25 February 2020

What this trial tests

trial testing Multiparametric magnetic resonance in Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification in 628 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
30 June 2020

31 December 2021

Quick facts

Lead sponsor	InvestigatorUrologyIBSAL
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	628
Start date	1 March 2020
Primary completion	30 June 2020
Estimated completion	31 December 2021
Sites	1 location across Spain

Drugs / interventions tested

• Multiparametric magnetic resonance

Conditions studied

• Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification — all drugs for 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 — all drugs for 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 — all drugs for 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 — all drugs for Establish the Association of the Tumor Biomarker in the Early Detection and Aggressiveness of Tumors →

Sponsor

InvestigatorUrologyIBSAL

Who can join

Adults 45 to 75, male only, with Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification or Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. microRNA-based diagnostic and therapeutic applications in cancer medicine.
   Sempere LF, Azmi AS, Moore A. · · 2021 · cited 97× · PMID 33998154 · DOI 10.1002/wrna.1662
2. Non-coding RNAs and epithelial mesenchymal transition in cancer: molecular mechanisms and clinical implications.
   Khanbabaei H, Ebrahimi S, García-Rodríguez JL, Ghasemi Z, et al · · 2022 · cited 36× · PMID 36114510 · DOI 10.1186/s13046-022-02488-x