Impact of Magnetic Resonance and Biomarkers for Screening... | NCT04283032

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

NCT04283032

Sponsor

InvestigatorUrologyIBSAL

Status

Unknown status

Last Update Posted

Feb 25, 2020Actual

Enrollment

628Estimated

Phase

Not provided

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

Interventions

Multiparametric magnetic resonance

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Feb 21, 2020

First Submission Date that Met QC Criteria

Feb 24, 2020

First Posted Date

Feb 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2020

Last Update Posted Date

Feb 25, 2020Actual

Name	Class
Instituto de Investigación Biomédica de Salamanca	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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

Detailed Description

Not provided

Conditions Module

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

Keywords

Prostate Cancer
Biomarkers
PSA
MMPm
Quality of Life

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

628Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Multiparametric magnetic resonance + transrectal biopsy	The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE)	Procedure: Multiparametric magnetic resonance
Multiparametric magnetic resonance + transperineal biopsy	The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP)	Procedure: Multiparametric magnetic resonance
Transrectal biopsy	The patient underwent a transrectal biopsy (BPTE)
Transperineal biopsy	The patient underwent a transperineal biopsy (BPTP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multiparametric magnetic resonance	Procedure	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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases