Prostate Cancer Clinical Trial
Official title:
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Over 18 years of age and willing and able to provide informed consent. - Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") - Including those men with: - an elevated PSA and no prior biopsy - an elevated PSA and a negative prior biopsy - Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort") Exclusion Criteria: - Patients with any clinical contraindication to MRI *Including but not limited to: - Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators - Those with cochlear implants - Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate) - Those who cannot lie flat for over 1 hour - Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | American Cancer Society, Inc., Midwest Stone Institute., National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve (AUC) comparison from biopsy and DBSI | As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis. |
Up to 12 weeks | |
Primary | Receiver operating characteristic (ROC) comparison from biopsy to DBSI | As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis. |
Up to 12 weeks | |
Primary | Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector | Up to 12 weeks | ||
Secondary | Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology | -Only for those patients with a suspicious MRI lesion | Up to 12 weeks | |
Secondary | Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation | Up to 12 weeks | ||
Secondary | Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation | Up to 12 weeks |
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