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

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ClinicalTrials.gov Identifier: NCT04283032
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Instituto de Investigación Biomédica de Salamanca
Information provided by (Responsible Party):
InvestigatorUrologyIBSAL, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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:

  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.


Condition or disease Intervention/treatment
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 Procedure: Multiparametric magnetic resonance

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 628 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Comparation between transrectal and transperineal prostatic biopsy with o without Magnetic Resonance [ Time Frame: 6 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Biomarker [-2] proPSA and PHI, microRNAs: miR-141, miR200C, hasa-miR-200b, miR-187, mir-188-5p, miR196b miR-151-3p, miR375, mir-16, miR25 and lec-7c.


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283032


Contacts
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Contact: Francisco Gomez Veiga 923291100 ext 55954 fgveiga@telefonica.net

Locations
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Spain
Francisco Gómez Veiga
Salamanca, Spain, 37007
Contact: Francisco Gomez Veiga, Dr.       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.         
Sponsors and Collaborators
InvestigatorUrologyIBSAL
Instituto de Investigación Biomédica de Salamanca
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Responsible Party: InvestigatorUrologyIBSAL, MD, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
ClinicalTrials.gov Identifier: NCT04283032    
Other Study ID Numbers: PI18/01560
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InvestigatorUrologyIBSAL, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León:
Prostate Cancer
Biomarkers
PSA
MMPm
Quality of Life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Aggression
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Behavioral Symptoms