Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 11:36 AM
Study NCT ID:
NCT05010759
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2021-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for Intermediate-Risk Prostate Cancer
Sponsor:
MagForce USA
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate enrollment and company changing direction
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: