Clinical trial · Interventional
High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ceased before all specimen collection and analysis could be completed
Summary
Brief summary (as posted)
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Diseases, Male | — | UNRESOLVED | — |
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Prostatic Disease | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM 1 (HIFU) - 18F-PSMA
- description
- 10 mCi ±20% F18-PSMA injection
- interventionNames
- Drug: 18F-PSMA
- type
- EXPERIMENTAL
- label
- ARM 2 (RP) - 18F-PSMA
- description
- 10 mCi ±20% F18-PSMA injection
- interventionNames
- Drug: 18F-PSMA
Primary outcomes (2)
- measure
- Primary Endpoint (HIFU): Identification of New Cancers
- timeFrame
- At time of pre-HIFU biopsy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy consisting of ≥ 10 tissue cores sampled 2. PSA \<20 ng/mL (for HIFU arm only) 3. cT1-cT2c 4. Either overall Gleason score \> 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core (for HIFU arm only) 5. Patient considering focal HIFU therapy or robotic radical prostatectomy Exclusion Criteria: 1. Previous local therapy for prostate cancer 2. Inability to receive PET tracer 3. Inability to receive MRI 4. Estimated glomerular filtration rate (GFR) \<15 mL/min/1.73 m2 5. Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
References
Publications (1)
- DERIVEDBasso Dias A, Ghai S, Ortega C, Mirshahvalad SA, Perlis N, Berlin A, Avery L, Veit-Haibach P, van der Kwast T, Metser U. Impact of 18F-DCFPyL PET/MRI in Selecting Men With Low-/Intermediate-Risk Prostate Cancer for Focal Ablative Therapies. Clin Nucl Med. 2023 Oct 1;48(10):e462-e467. doi: 10.1097/RLU.0000000000004819. PMID 37682613