Prostatic NeoplasmNCT04398173
Detection Rate of Prostate Cancer in Men Undergoing MRI
An observational study of Prostatic Neoplasm, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- multiparametric MRI
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2014to 31 Dec 2020
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with clinical suspicion of PCa, eligible for prostate biopsy
Who may be able to join
- age 50 and life expectancy greater than 10 years
- PSA values persistently greater than 4 ng/ml
- multiparametric MRI of the prostate between nov-2014 and nov-2016
- MRI with endorectal coil
Who cannot join
- previous history of PCa
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
Candiolo, Turin, 10060
About this study
Official title: A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy.
Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
Read the detailed description
The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy.
To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score >= 3) and biopsy data will be considered.
In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.
- Conditions
- Prostatic Neoplasm
- Being tested
- multiparametric MRI
- Keywords
- magnetic resonance imaging, prostate biopsy
- 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 MRIDiagnostic test
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
| Study group | Role | What they receive |
|---|---|---|
| Group A (previous negative biopsy) | Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI Receives: Diagnostic Test: multiparametric MRI | |
| Group B (biopsy naive) | Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI Receives: Diagnostic Test: multiparametric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCa detection rate
Number of men with positive prostate biopsy over the number of men with a positive MRI
Measured: 24 months
Secondary outcomes (1)
Negative predictive value of MRI
Number of men with negative MRI or positive MRI but negative biopsy who are confirmed as negative for PCa during the follow-up over the total number of subjects considered during the follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Nov 2014
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398173
- Sponsor's protocol ID
- ProBiopsy-RM19
- Status last verified
- Apr 2021
- First submitted
- 30 Jan 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men
- ClinicalTrials.gov ID
- NCT04398173
- Acronym / sponsor ID
- ProBiopsy-RM19
- Conditions
- Prostatic Neoplasm
- Keywords
- magnetic resonance imaging, prostate biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 May 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.
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy.
Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
Detailed description
The trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of PCa who will undergo MRI. Group A is composed by patients with previous negative biopsy, while group B is composed by men with no previous negative prostate biopsy.
To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score >= 3) and biopsy data will be considered.
In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (previous negative biopsy) | – | Diagnostic Test: multiparametric MRIMen with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI |
| Group B (biopsy naive) | – | Diagnostic Test: multiparametric MRIMen with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with clinical suspicion of PCa, eligible for prostate biopsy
Key inclusion criteria (4 listed)
- age 50 and life expectancy greater than 10 years
- PSA values persistently greater than 4 ng/ml
- multiparametric MRI of the prostate between nov-2014 and nov-2016
- MRI with endorectal coil
Key exclusion criteria (1 listed)
- previous history of PCa
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 MRIT1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging | Diagnostic test | Group A (previous negative biopsy), Group B (biopsy naive) |
Primary outcome
PCa detection rate
Time frame: 24 months
Number of men with positive prostate biopsy over the number of men with a positive MRI
1 secondary outcome
Negative predictive value of MRI
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostatic Neoplasm, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCa detection rate (time frame: 24 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 14 Apr 2021.