Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
About this study
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.
- Condition
- Prostate Cancer
- Sponsor
- Virdx, Inc.
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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.
Exclusion 6
- 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.).
Where
1 site, 1 recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, Brazil
Contact
-
Sina Knapp, PhD
+4917680891277 sina.knapp@virdx.com
Potential match only. Final eligibility is determined by the study team.