Status:
COMPLETED
MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Trod Medical N.V.
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02303054
Start Date
September 1 2014
End Date
March 1 2016
Last Update
October 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Smilow Comprehensive Prostate Cancer Center
New York, New York, United States, 10016