MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer (FUSAblate)

NYU Langone Health

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Bipolar Radiofrequency Focal Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02303054

14-00903

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Bipolar Radiofrequency Focal Ablation

Experimental group

Description:

Men identified as having suspicious regions on an Prostatic multi-parametric MRI (mpMRI) of the prostate will be considered for enrollment. If followed by a positive MRI-US targeted biopsy of the prostate, men who be offered enrollment into the study. All men enrolled in the study will undergo bipolar radiofrequency ablation. Efficacy will be assessed through MRI-US biopsy after focal bipolar RFA.

Treatment:

Procedure: Bipolar Radiofrequency Focal Ablation