Using PSMA PET to improve detection of significant prostate cancer lesions during MRI-targeted biopsy
Official title: The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA): a Prospective, Paired Diagnostic Study
Run by Jules Bordet Institute · NCT06867588 · Data updated 2026-11-12
This study is testing if a special type of imaging called PSMA PET can help find important prostate cancer spots that might be missed during regular MRI-targeted biopsies in men with high-risk localized prostate cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 68 (estimated) |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | October 17, 2024 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | March 31, 2025 |
| Trial ID | NCT06867588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are men aged 18 and older who have undergone a multiparametric MRI within the last six months and have at least one lesion classified as PI-RADS 3.
✕Probably not a fit
Patients who have previously been diagnosed with prostate cancer through MRI-targeted biopsy or have lesions classified as PI-RADS 4-5 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Prostate Specific Membrane Antigen (PSMA) PET imaging in detecting clinically significant prostate cancer lesions in men undergoing MRI-targeted biopsy. By comparing the accuracy of PSMA PET with conventional imaging methods, the study aims to enhance the detection rates of metastatic disease, particularly in patients with high-risk localized prostate cancer. Participants will undergo PSMA PET imaging after having a multiparametric MRI within the last six months, focusing on lesions classified as PI-RADS 3. The goal is to determine if PSMA PET can provide added value in identifying significant cancer lesions that may be missed by standard imaging techniques.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate detection of prostate cancer, allowing for better-targeted treatments and improved patient outcomes.
How similar studies have gone: Other studies have shown that PSMA PET imaging significantly outperforms conventional imaging methods in detecting prostate cancer, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet the following criteria for inclusion in the study: * Men ≥ 18 years of age * Multiparametric MRI within the previous 6 months * At least one lesion PI-RADS 3 * Able to provide written informed consent Exclusion Criteria: Eligible subjects must not meet any of the exclusion criteria listed below: * Previous prostate cancer diagnostic on MRI-targeted biopsy * At least one lesion PI-RADS 4-5 * Negative MRI (PI-RADS 1-2) * Previous treatment for prostate cancer 11 * Contraindication to PSMA PET and/or MRI and/or prostate biopsy * Low quality of MRI defined by a PI-QUAL score of 1 or 2 * Any medical condition that may interfere with the study procedures.
Where it's running
-
Institut Jules Bordet
Brussels, Belgium Recruiting
Study contacts
- Study coordinator: Romain Diamand
- Email: romain.diamand@hubruxelles.be
- Phone: 003225413781
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.