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

NCT05010759 | Terminated FDA Device

• 1 other identifier: MGF-0115 - Stage 2B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 4

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Ablation Success

  Rate of subjects with a biopsy confirmed ablation of prostate cancer lesion

  4 months (+/- 1 Month)

Secondary Outcomes (1)

• Adverse Event Rate

  4 months (+/- 1 Month)

Study Arms (1)

Ablation Arm

EXPERIMENTAL

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.

Device: NanoTherm Ablation

Interventions

NanoTherm Ablation DEVICE

Iron nanoparticles are instilled into the prostate cancer lesion and then the particles are heated using a magnetic field and this heating ablates the prostate cancer lesion.

Ablation Arm

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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®

Sponsors & Collaborators

• MagForce USA: lead

Study Sites (4)

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Urology Austin

Austin, Texas, 78759, United States

Location

MagForce - San Antonio

San Antonio, Texas, 78229, United States

Location

MagForce USA

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Hammond, MS

  MagForce USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: November 30, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)