MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02303054
- Run by
- NYU Langone Health
- People needed
- 21
- Starts
- 2014-09-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-10-11
Who can join
Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
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:
- 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
You may not qualify if…
- 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
Where it is running
- Smilow Comprehensive Prostate Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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