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

Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Bipolar Radiofrequency Focal Ablation

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Smilow Comprehensive Prostate Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bipolar Radiofrequency Focal Ablation; 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.

Procedure: Bipolar Radiofrequency Focal Ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after focal bipolar radiofrequency ablation (RFA)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week; 2 week; 1 month; 3 months; 6 months
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	1 week; 2 week; 1 month; 3 months; 6 months
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	1 week; 2 week; 1 month; 3 months; 6 months
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	1 week; 2 week; 1 month; 3 months; 6 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Trod Medical N.V.
• Investigators: Principal Investigator: Samir S Taneja, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 8, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Prostate Cancer; Focal Therapy; Focal Ablation; MRI-US Fusion Biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 14-00903

Drug and device information, study documents

• 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