Clinical trial · Interventional
Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
NCT07568756CI-TRIAL-00110507not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flotufolastat F18 PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Post-Focal Therapy Flotufolastat F18PET
- description
- Post-Focal Therapy Flotufolastat F18 PET
- interventionNames
- Diagnostic Test: Flotufolastat F18 PET
Primary outcomes (1)
- measure
- Flotufolastat F18 PET findings
- timeFrame
- 5 years
- description
- Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.
Secondary outcomes (3)
- measure
- Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or greater at time of consent * Prostate adenocarcinoma (no other histologic subtypes allowed) * Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife) * Multiparametric-MRI imaging planned * Planned pre- and post- treatment MRI-fusion biopsy Exclusion Criteria: * Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy) * Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease * PSA \>10 * High-risk prostate cancer (diagnosed by biopsy) * Bilateral prostatic lobe disease
References
Publications (0)
Data not yet available
No reference posted for this study.