Prostate CancerNCT07432360
Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
An observational study of Prostate Cancer, run by Virdx, Inc. at 1 site in Brazil.
Trial summary
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jan 2026to Jun 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the Instituto do Câncer do Estado de São Paulo
Who may be able to join
- Humans with a prostate ≥18 years of age.
- Patients with biopsy-proven PCa who are scheduled for an RPE.
- Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.
- Willingness, ability, and legal capacity to participate in the study.
- Ability to adhere to the prohibitions and restrictions defined in this protocol.
Who cannot join
- Inability to give consent.
- Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).
- Prior PCa treatment.
- Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.
- Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.
- General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo
About this study
Official title: Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with biopsy-proven PCa who are scheduled for RPE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different microstructure models in the performance of detecting csPCa
Measured: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start28 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Virdx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Marcelo Araujo Queiroz, MD PhD, Principal investigator, Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432360
- Sponsor's protocol ID
- VIRDX 2025_BR
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07432360
- Acronym / sponsor ID
- VIRDX 2025_BR
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Virdx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with biopsy-proven PCa who are scheduled for RPE | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Instituto do Câncer do Estado de São Paulo
Key inclusion criteria (5 listed)
- Humans with a prostate ≥18 years of age.
- Patients with biopsy-proven PCa who are scheduled for an RPE.
- Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.
- Willingness, ability, and legal capacity to participate in the study.
- Ability to adhere to the prohibitions and restrictions defined in this protocol.
Key exclusion criteria (6 listed)
- Inability to give consent.
- Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).
- Prior PCa treatment.
- Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.
- Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of different microstructure models in the performance of detecting csPCa
Time frame: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Marcelo Araujo Queiroz, MD PhD principal investigator
Instituto do Câncer do Estado de São Paulo
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 Prostate Cancer, run by Virdx, Inc. at 1 site in Brazil.
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 6 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sina Knapp, PhD (+4917680891277, sina.knapp@virdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of different microstructure models in the performance of detecting csPCa (time frame: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)). 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 2026.