Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason ClassificationRMPBX201801NCT04283032
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis
An observational study of Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification and Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique, run by InvestigatorUrologyIBSAL at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is 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, Establish the Efficacy Between the Four Schemes in Terms of the Patient's Subjective Perception Regarding Pain and Quality of Life
- What is being tested?
- Multiparametric magnetic resonance
- Type of treatment
- Surgery or procedure
- How many people
- 628 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 31 Dec 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Francisco Gómez Veiga
Salamanca, 37007
Francisco Gomez Veiga, Dr., fgveiga@telefonica.net
Alvaro Virseda Rodríguez, Dr
About this study
Official title: 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:
- 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.
Read more
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.
- 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
- Being tested
- Multiparametric magnetic resonance
- Keywords
- Prostate Cancer, Biomarkers, PSA, MMPm, Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric magnetic resonanceProcedure or surgery
Also called Transrectal biopsy, Transperineal biopsy
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).
| Study group | Role | What they receive |
|---|---|---|
| Multiparametric magnetic resonance + transrectal biopsy | The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE) Receives: Procedure: Multiparametric magnetic resonance | |
| Multiparametric magnetic resonance + transperineal biopsy | The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP) Receives: Procedure: Multiparametric magnetic resonance | |
| Transrectal biopsy | The patient underwent a transrectal biopsy (BPTE) | |
| Transperineal biopsy | The patient underwent a transperineal biopsy (BPTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason ClassificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 628 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- InvestigatorUrologyIBSAL
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor-investigator, InvestigatorUrologyIBSAL, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283032
- Sponsor's protocol ID
- PI18/01560
- Acronym
- RMPBX201801
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)
- ClinicalTrials.gov ID
- NCT04283032
- Acronym / sponsor ID
- RMPBX201801 / PI18/01560
- 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
- Keywords
- Prostate Cancer, Biomarkers, PSA, MMPm, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- InvestigatorUrologyIBSALUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multiparametric magnetic resonance + transrectal biopsy | – | Procedure: Multiparametric magnetic resonanceThe patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE) |
| Multiparametric magnetic resonance + transperineal biopsy | – | Procedure: Multiparametric magnetic resonanceThe patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP) |
| Transrectal biopsy | – | –The patient underwent a transrectal biopsy (BPTE) |
| Transperineal biopsy | – | –The patient underwent a transperineal biopsy (BPTP) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric magnetic resonanceAlso: Transrectal biopsy, Transperineal biopsyMRI 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). | Procedure or surgery | Multiparametric magnetic resonance + transperineal biopsy, Multiparametric magnetic resonance + transrectal biopsy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification and Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique, run by InvestigatorUrologyIBSAL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Gomez Veiga (923291100 ext. 55954, fgveiga@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparation between transrectal and transperineal prostatic biopsy with o without Magnetic Resonance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.