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

NCT02303054 | Completed DMC

• 1 other identifier: 14-00903
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Focal Ablation; MRI-US Fusion Biopsy; Focal Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation

  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

  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

  1 week; 2 week; 1 month; 3 months; 6 months

• Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation

  1 week; 2 week; 1 month; 3 months; 6 months

Study Arms (1)

Bipolar Radiofrequency Focal Ablation

EXPERIMENTAL

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

Interventions

Bipolar Radiofrequency Focal Ablation PROCEDURE

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.

Bipolar Radiofrequency Focal Ablation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Histology other than adenocarcinoma
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Trod Medical N.V.: collaborator

Study Sites (1)

Smilow Comprehensive Prostate Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Samir S Taneja, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: November 27, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

US (1)