New imaging technique for detecting prostate cancer
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
This study is testing a new MRI technique to see if it can help men with elevated PSA levels or those under active surveillance for prostate cancer get diagnosed earlier and more accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04420702 on ClinicalTrials.gov |
What this trial studies
This study evaluates Diffusion Basis Spectrum Imaging (DBSI), a non-invasive MRI technique aimed at improving the early detection of clinically significant prostate cancer. It targets men over 18 years old who are either planning to undergo a prostate biopsy due to elevated PSA levels or are currently under active surveillance for previously diagnosed prostate cancer. The study will assess the effectiveness of DBSI in identifying prostate cancer compared to standard imaging methods. Participants will be recruited from Washington University School of Medicine in Saint Louis, Missouri.
Who should consider this trial
Good fit: Ideal candidates include men over 18 with elevated PSA levels who have not been previously diagnosed with prostate cancer or those currently under active surveillance.
Not a fit: Patients with clinical contraindications to MRI, such as those with metallic implants or severe claustrophobia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could lead to earlier and more accurate detection of prostate cancer, potentially improving patient outcomes.
How similar studies have performed: While the approach of using advanced imaging techniques for prostate cancer detection is being explored, the specific application of DBSI is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Ippolito, M.D. — Washington University School of Medicine
- Study coordinator: Joseph Ippolito, M.D.
- Email: ippolitoj@wustl.edu
- Phone: 314-362-2925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.