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

NCT ID: NCT02303054

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Focal Ablation MRI-US Fusion Biopsy Focal Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bipolar Radiofrequency Focal Ablation

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.

Group Type EXPERIMENTAL

Bipolar Radiofrequency Focal Ablation

Intervention Type PROCEDURE

Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.

Interventions

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Bipolar Radiofrequency Focal Ablation

Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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

Exclusion Criteria

* Histology other than adenocarcinoma
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Trod Medical N.V.

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir S Taneja, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Smilow Comprehensive Prostate Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-00903

Identifier Type: -

Identifier Source: org_study_id