Clinical trial · Interventional
MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
NCT02680535CI-TRIAL-00050434completedN/AClinicalTrials.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)
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
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 |
|---|---|---|---|
| Neoplasms of the Prostate | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AuroShell particle infusion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AuroShell particle infusion
- description
- Single intravenous infusion of AuroShell particles 12 to 36 hours prior to ultrasound-guided laser irradiation using a FDA cleared laser and an interstitial optical fiber.
- interventionNames
- Device: AuroShell particle infusion
Primary outcomes (1)
- measure
- Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment.
- timeFrame
- Three Months
- description
- Efficacy of focal ablation will be assessed by 3T MRI/Ultrasound guided biopsy at 3 months after treatment. Focal ablation of clinically significant targeted prostate lesions(s) as confirmed with negative biopsies with minimal damage to surrounding healthy tissue.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have documented histological or cytological evidence of tumor(s) of the prostate. * Patients must be ≥ 45 years of age * Patients or their legal representative must be able to read, understand and sign an informed consent * Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging * Prostate cancer is diagnosed by MR image guided biopsies * Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy. * If the standard biopsy cores are positive, they must be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (Left / Right, Base, Mid Gland, Apex). * Prior MRI results dated within 120 days prior to ablation. * No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA \> 20 or T2 and PSA \> 10 * PSA \< 15 ng/ml or PSA density \< 0.15 ng/ml2 in patients with a PSA \> 15 ng/ml * The patient has given written informed consent after the nature of the study and alternative treatment options have been explained Exclusion Criteria: * Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold) * Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) * Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing * Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. * The presence of 3 or more MR Visible lesions positive on biopsy. * The presence of extra capsular, seminal vesicle invasion or metastatic disease. * Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc…) * Patient with inability to follow up. * History of prior treatment for prostate cancer. * Acute urinary tract infection. * Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) \> 20 * Patients with renal insufficiency with an estimated glomerular filtration (EGF) \<= 30 are excluded, due to they will not be able to undergo gadolinium enhance MRI. * Patients with acute or chronic hepatic dysfunction as evidenced by clinically significant abnormalities in albumin, total protein, or prothrombin time, or evidence of hepatic injury with clinically important (\> grade 1) changes in AST, ALT, ALP, bilirubin, or GGT values. * Patients with uncontrolled coagulopathies who are at increased risk of bleeding. * Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes. * Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
References
Publications (2)
- DERIVEDCanfield SE, George AK, Jue JS, Lewis SC, Davenport MS, Tammisetti VS, Maruf M, Borregalaes LD, Kadria-Vili Y, Schwartz JA, West J, Halas NJ, Rastinehad AR. A Multi-Institutional Study of Magnetic Resonance/Ultrasound Fusion-Guided Nanoparticle-Directed Focal Therapy for Prostate Ablation. J Urol. 2024 Dec;212(6):862-872. doi: 10.1097/JU.0000000000004222. Epub 2024 Sep 3. PMID 39226591
- DERIVEDJue JS, Coons S, Hautvast G, Thompson SF, Geraats J, Richstone L, Schwartz MJ, Rastinehad AR. Novel Automated Three-Dimensional Surgical Planning Tool and Magnetic Resonance Imaging/Ultrasound Fusion Technology to Perform Nanoparticle Ablation and Cryoablation of the Prostate for Focal Therapy. J Endourol. 2022 Mar;36(3):369-372. doi: 10.1089/end.2021.0266. Epub 2021 Sep 13. PMID 34409850