Clinical trial · Interventional
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA
Single-center Study for Biopsy Guidance Using Gallium-68 Labeled Prostate-specific Membrane Antigen (PSMA) PET/MRI in Patients With Elevated PSA Eligible for Prostate Biopsy in Comparison to Multiparametric MRI.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of \[68Ga\]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]PSMA-1007 | Drug | — | UNRESOLVED |
| [68Ga]PSMA-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PET/MRI before biopsy
- description
- Patients with suspected areas on mpMRI will undergo additional \[68Ga\]PSMA-11 PET/MRI scan with subsequent mpMRI and PET/MRI guided biopsy.
- interventionNames
- Drug: [68Ga]PSMA-11
- Drug: [18F]PSMA-1007
- type
- EXPERIMENTAL
- label
- PET/MRI after biopsy
- description
- Patients with unclear areas or a negative finding in the mpMRI for MRI guided biopsy but positive biopsy, which will undergo the additional \[68Ga\]PSMA-11 PET/MRI scan with \[68Ga\]PSMA.
- interventionNames
- Drug: [68Ga]PSMA-11
Primary outcomes (1)
- measure
- Rate of positive histopathology for [68Ga]PSMA-11 positive lesions
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously undiagnosed patients with elevated PSA (ages 30-50 PSA \>2.5 ng/mL; ages 50-80 PSA \> 4ng/mL), eligible for prostate needle biopsy. 2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer 3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B). 4. Written informed consent 5. Age \> 30 Exclusion Criteria: 1. Age\> 80 2. Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies) 3. Active urinary tract infection or indwelling catheter 4. Prior pelvic irradiation 5. Prior prostatectomy 6. Prior androgen deprivation hormonal therapy 7. Prostate biopsy within 8 weeks prior to study 8. Prior transurethral resection of the prostate (TURP)
References
Publications (2)
- DERIVEDFerraro DA, Laudicella R, Zeimpekis K, Mebert I, Muller J, Maurer A, Grunig H, Donati O, Sapienza MT, Rueschoff JH, Rupp N, Eberli D, Burger IA. Hot needles can confirm accurate lesion sampling intraoperatively using [18F]PSMA-1007 PET/CT-guided biopsy in patients with suspected prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1721-1730. doi: 10.1007/s00259-021-05599-3. Epub 2021 Nov 2. PMID 34725726
- DERIVEDFerraro DA, Becker AS, Kranzbuhler B, Mebert I, Baltensperger A, Zeimpekis KG, Grunig H, Messerli M, Rupp NJ, Rueschoff JH, Mortezavi A, Donati OF, Sapienza MT, Eberli D, Burger IA. Diagnostic performance of 68Ga-PSMA-11 PET/MRI-guided biopsy in patients with suspected prostate cancer: a prospective single-center study. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3315-3324. doi: 10.1007/s00259-021-05261-y. Epub 2021 Feb 23. PMID 33620559