MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 10/13/2017 |
| Start Date: | September 2014 |
| End Date: | March 2016 |
Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)
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.
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.
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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