Clinical trial NCT02303054: MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer
Official title: Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Focal Ablation
MRI-US Fusion Biopsy
Focal Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Trod Medical N.V.
First posted: 2014-11-27
Enrollment: 21
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
timeFrame: 6 months after focal bipolar radiofrequency ablation (RFA)
Secondary outcomes:
measure: International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation
timeFrame: 1 week; 2 week; 1 month; 3 months; 6 months
measure: Expanded Prostate Cancer Index Composite (EPIC) Score to Measure Quality of Life Post Focal Ablation
timeFrame: 1 week; 2 week; 1 month; 3 months; 6 months
measure: International Index of Erectile Function questionnaires Score (IEFF) to Measure Quality of Life Post Focal Ablation
timeFrame: 1 week; 2 week; 1 month; 3 months; 6 months
measure: Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation
timeFrame: 1 week; 2 week; 1 month; 3 months; 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Smilow Comprehensive Prostate Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Samir S Taneja, MD
role: PRINCIPAL_INVESTIGATOR
References: