Clinical trial · Interventional
Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for Intermediate-Risk Prostate Cancer
Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer
NCT05010759CI-TRIAL-00068406terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate enrollment and company changing direction
Summary
Brief summary (as posted)
Stage 2B: NanoTherm ablation of focal prostate cancer in small lesions in Gleason 3+4 disease. The outcome of this ablation is validated by a transperineal biopsy at 4 months after ablation.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoTherm Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ablation Arm
- description
- Subjects in this arm of the study will have focal ablation of the prostate cancer lesion with the NanoTherm technology. This ablation will be followed-up transperineal prostate biopsy at 4 months after treatment.
- interventionNames
- Device: NanoTherm Ablation
Primary outcomes (1)
- measure
- Rate of Ablation Success
- timeFrame
- 4 months (+/- 1 Month)
- description
- Rate of subjects with a biopsy confirmed ablation of prostate cancer lesion
Secondary outcomes (1)
- measure
- Adverse Event Rate
- timeFrame
- 4 months (+/- 1 Month)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 40 to 85 * Male * Prostate adenocarcinoma on biopsy * Clinical stage T1c/T2a/T2b, N0, M0/Mx with no lesion larger than 2cc in volume * The following biopsy findings (biopsy must have MRI visualization and be within 6 months of planned NanoTherm® treatment): * A positive biopsy for prostate cancer from the MRI-visualized lesion, at least one of which must be Gleason 3+4 (grade group 2) * Lesion must be visualized by Multiparametric Magnetic Resonance Imaging (MP-MRI) on a scan that is less than 6 months old * Patient expresses a preference for active surveillance, rather than surgery or radiation, to manage prostate cancer * Based on the evaluation of the study investigator, appropriate for instillation of NanoTherm® under anesthesia based on location and size of the clinical target volume (CTV) Exclusion Criteria: * Previous treatment for cancer with radiation, androgen deprivation (including LHRH-agonists or antagonists or antiandrogens), or surgery for prostate cancer * Active urinary tract infection * Metallic implants below the neck * Gleason 3+4 or higher cancer on prostate biopsy outside of the planned CTV * Gleason 4+3 or higher on any prostate biopsy * Hematological abnormality indicating increased risk of bleeding or clotting, for example low platelet count or anemia * Participation concurrently in another clinical trial for prostate disease or in the last 30 days * Known hypersensitivity to Axumin®
References
Publications (0)
Data not yet available
No reference posted for this study.