An interventional study of Bipolar Radiofrequency Focal Ablation in Prostate Cancer, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 21 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Subject Population:
Pre-enrollment biopsy parameters:
Final enrollment biopsy parameters after fusion biopsy:
Exclusion Criteria:
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.
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.
Time frame: 6 months after focal bipolar radiofrequency ablation (RFA)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week; 2 week; 1 month; 3 months; 6 months
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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