Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for Intermediate-Risk Prostate Cancer

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05010759

Run by

MagForce USA

People needed

3

Starts

2021-11-30

Expected to finish

2023-07-28

Last updated by the study team

2023-08-01

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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®

Where it is running

• Florida Urology Partners — Tampa, Florida, United States
• Urology Austin — Austin, Texas, United States
• MagForce - San Antonio — San Antonio, Texas, United States
• MagForce USA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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