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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05010759
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
MagForce USA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: NanoTherm Ablation Not Applicable

Detailed Description:

Presently, patients having intermediate-risk prostate carcinoma have to make a very difficult decision regarding treatment, as active surveillance will not immediately alter the current quality of life. However, because there is a risk of progressive disease or due to patient anxiety due to an untreated tumor, many patients opt for active treatment, often using radiation or prostatectomy, and sometimes in combination with androgen deprivation. Unfortunately, radiation, surgery, and androgen deprivation have multiple and potentially profound side effects including sexual, urinary, and bowel complications. As a small fraction of men dies from this disease, the number of men needed to treat to prevent one death is large, resulting in many men with side effects or complications to help prevent the one death. It is for these reasons that there is a major need for focal therapy for this group of patients who most commonly are treated actively with surgery or radiation; such focal therapy could ablate the detected tumor(s) within the prostate, control the disease while avoiding side effects of whole gland therapies and controlling tumor growth within the prostate detected by (multiparameter-) MRI and histopathologically confirmed by biopsy. MagForce NanoTherm® Therapy offers this option by noninvasive ablation of small tumors in a 1-2 ml target volume of the prostate, a treatment that is not possible with any other technology on the market.

This study evaluates the use of NanoTherm ablation as a method of treating these intermediate grade lesions allowing patients to return to active surveillance without definitive treatment such as external beam radiation or prostatectomy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ablation Arm
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Ablation Success [ Time Frame: 4 months (+/- 1 Month) ]
    Rate of subjects with a biopsy confirmed ablation of prostate cancer lesion


Secondary Outcome Measures :
  1. Adverse Event Rate [ Time Frame: 4 months (+/- 1 Month) ]
    Rate of Adverse Events of Special Interest (AESI)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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®
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010759


Contacts
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Contact: Lee Anne Loek, RN 833-287-1150 prostatestudy@magforce-usa.com
Contact: Michael Gonzalez 833-287-1150 prostatestudy@magforce-usa.com

Locations
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United States, Florida
Florida Urology Partners Recruiting
Tampa, Florida, United States, 33615
Contact: Linda Seibert       linda@gulfcoastcta.com   
Principal Investigator: Osvaldo Padron, MD         
United States, Texas
Urology Austin Recruiting
Austin, Texas, United States, 78759
Contact: Jennifer Penshorn       jennifer.penshorn@urologyaustin.com   
Principal Investigator: Brian Mazzarella, MD         
MagForce - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Lee Anne Loek, RN       prostatestudy@magforce-usa.com   
Contact: Michael Gonzalez       prostatestudy@magforce-usa.com   
Principal Investigator: Ian Thompson Jr., MD         
Sub-Investigator: Ian Thompson III, MD         
United States, Washington
MagForce USA Recruiting
Seattle, Washington, United States, 98105
Contact: LeeAnne Loek, RN       prostatestudy@magforce-usa.com   
Contact: Michael Gonzalez       prostatestudy@magforce-usa.com   
Principal Investigator: Laurence Lee, MD         
Sponsors and Collaborators
MagForce USA
Investigators
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Study Director: David Hammond, MS MagForce USA
More Information
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Responsible Party: MagForce USA
ClinicalTrials.gov Identifier: NCT05010759    
Other Study ID Numbers: MGF-0115 - Stage 2B
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases