Prostate Cancer
Conditions
Keywords
Prostate Cancer, Focal Ablation, MRI-US Fusion Biopsy, Focal Therapy
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.
Interventions
PROCEDUREBipolar 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.
Sponsors
Trod Medical N.V.
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy | 6 months after focal bipolar radiofrequency ablation (RFA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation | 1 week; 2 week; 1 month; 3 months; 6 months | 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 |
| 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 | 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 |
| 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 | 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 |
| Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation | 1 week; 2 week; 1 month; 3 months; 6 months | Participants will be asked to complete SF-12 questionnaires at each time frame to evaluate any baseline changes in functional health and well-being |
Countries
United States
Outcome results
None listed