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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303054
• Other study ID #: 14-00903
• Status: Completed
• Phase: N/A
• First received: November 8, 2014
• Last updated: October 9, 2017
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Smilow Comprehensive Prostate Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Trod Medical N.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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