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| Name | Class |
|---|---|
| Trod Medical N.V. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Subject Population:
Pre-enrollment biopsy parameters:
Final enrollment biopsy parameters after fusion biopsy:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir S Taneja, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Comprehensive Prostate Cancer Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |