Prostate Cancer Clinical Trial
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
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.
Eligibility Criteria
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
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There is 1 Location for this study
New York New York, 10016, United States
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