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MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer (FUSAblate)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bipolar Radiofrequency Focal Ablation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Focal Ablation, MRI-US Fusion Biopsy, Focal Therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject Population:

  • Men 40-80 years of age
  • Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy
  • No prior treatment for prostate cancer
  • Prostate Cancer Clinical Stage T1c
  • Prostate-specific antigen (PSA)<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
  • Declined all standard treatment options

Pre-enrollment biopsy parameters:

  • Minimum of 12 biopsy cores
  • Gleason 6 (3+3) or 7 (3+4)

Final enrollment biopsy parameters after fusion biopsy:

  • 12 standard biopsy cores plus targeted regions based upon MRI
  • Gleason 6 (3+3) or 7 (3+4)
  • No demonstrated cancer diameter >1.2 cm

Exclusion Criteria:

  • Histology other than adenocarcinoma
  • Biopsy does not meet inclusion criteria
  • History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA)
  • History of prior pelvic radiation
  • Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months
  • Contraindication for Multiparametric-MRI

Sites / Locations

  • Smilow Comprehensive Prostate Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bipolar Radiofrequency Focal Ablation

Arm Description

Men identified as having suspicious regions on an Prostatic multi-parametric MRI (mpMRI) of the prostate will be considered for enrollment. If followed by a positive MRI-US targeted biopsy of the prostate, men who be offered enrollment into the study. All men enrolled in the study will undergo bipolar radiofrequency ablation. Efficacy will be assessed through MRI-US biopsy after focal bipolar RFA.

Outcomes

Primary Outcome Measures

Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
The primary endpoint of the trial will be assessed at 6 months after focal bipolar RFA by repeat mp-MRI imaging and fusion biopsy. Treatment efficacy, defined as a negative, will be determined by the results of the MRI-US targeted biopsy that will include regions treated by focal bipolar RFA.

Secondary Outcome Measures

International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation
Participants will be asked to complete international prostate symptom score (IPSS) questionnaires at each time frame to determine any baseline changes from voiding symptoms following focal RFA
Expanded Prostate Cancer Index Composite (EPIC) Score to Measure Quality of Life Post Focal Ablation
Participants will be asked to complete EPIC questionnaires at each time frame to evaluate any baseline changes in patient function and bother following focal RFA
International Index of Erectile Function questionnaires Score (IEFF) to Measure Quality of Life Post Focal Ablation
Participants will be asked to complete International Index of Erectile Function (IIEF) - 15 questionnaires at each time frame to evaluate any baseline changes in erectile function following focal RFA
Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation
Participants will be asked to complete SF-12 questionnaires at each time frame to evaluate any baseline changes in functional health and well-being

Full Information

First Posted
November 8, 2014
Last Updated
October 9, 2017
Sponsor
NYU Langone Health
Collaborators
Trod Medical N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02303054
Brief Title
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Acronym
FUSAblate
Official Title
Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Trod Medical N.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Focal Ablation, MRI-US Fusion Biopsy, Focal Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bipolar Radiofrequency Focal Ablation
Arm Type
Experimental
Arm Description
Men identified as having suspicious regions on an Prostatic multi-parametric MRI (mpMRI) of the prostate will be considered for enrollment. If followed by a positive MRI-US targeted biopsy of the prostate, men who be offered enrollment into the study. All men enrolled in the study will undergo bipolar radiofrequency ablation. Efficacy will be assessed through MRI-US biopsy after focal bipolar RFA.
Intervention Type
Procedure
Intervention Name(s)
Bipolar Radiofrequency Focal Ablation
Intervention Description
Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.
Primary Outcome Measure Information:
Title
Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
Description
The primary endpoint of the trial will be assessed at 6 months after focal bipolar RFA by repeat mp-MRI imaging and fusion biopsy. Treatment efficacy, defined as a negative, will be determined by the results of the MRI-US targeted biopsy that will include regions treated by focal bipolar RFA.
Time Frame
6 months after focal bipolar radiofrequency ablation (RFA)
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation
Description
Participants will be asked to complete international prostate symptom score (IPSS) questionnaires at each time frame to determine any baseline changes from voiding symptoms following focal RFA
Time Frame
1 week; 2 week; 1 month; 3 months; 6 months
Title
Expanded Prostate Cancer Index Composite (EPIC) Score to Measure Quality of Life Post Focal Ablation
Description
Participants will be asked to complete EPIC questionnaires at each time frame to evaluate any baseline changes in patient function and bother following focal RFA
Time Frame
1 week; 2 week; 1 month; 3 months; 6 months
Title
International Index of Erectile Function questionnaires Score (IEFF) to Measure Quality of Life Post Focal Ablation
Description
Participants will be asked to complete International Index of Erectile Function (IIEF) - 15 questionnaires at each time frame to evaluate any baseline changes in erectile function following focal RFA
Time Frame
1 week; 2 week; 1 month; 3 months; 6 months
Title
Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation
Description
Participants will be asked to complete SF-12 questionnaires at each time frame to evaluate any baseline changes in functional health and well-being
Time Frame
1 week; 2 week; 1 month; 3 months; 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject Population: Men 40-80 years of age Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy No prior treatment for prostate cancer Prostate Cancer Clinical Stage T1c Prostate-specific antigen (PSA)<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy) Declined all standard treatment options Pre-enrollment biopsy parameters: Minimum of 12 biopsy cores Gleason 6 (3+3) or 7 (3+4) Final enrollment biopsy parameters after fusion biopsy: 12 standard biopsy cores plus targeted regions based upon MRI Gleason 6 (3+3) or 7 (3+4) No demonstrated cancer diameter >1.2 cm Exclusion Criteria: Histology other than adenocarcinoma Biopsy does not meet inclusion criteria History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA) History of prior pelvic radiation Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months Contraindication for Multiparametric-MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir S Taneja, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Comprehensive Prostate Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer

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