Focal Prostate Radio-Frequency Ablation



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/13/2018
Start Date:December 29, 2014
End Date:April 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

The main purpose of this study is to evaluate the safety and efficacy of focal (targeted)
Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized
prostate cancer.


Inclusion Criteria:

- Men 18 years of age or older

- Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center
review

- No prior treatment for prostate cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1

- Prostate Cancer Clinical Stage T2a and below

- PSA <10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the
initial prostate biopsy)

- Prostate size <60 cc on transrectal ultrasound

- Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10
biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or
left-sided, not bilateral).

Exclusion Criteria:

- Men less than 18 years of age

- Medically unfit for anesthesia

- Histology other than adenocarcinoma

- Biopsy does not meet inclusion criteria

- Men who have received any hormonal manipulation (antiandrogens; Luteinizing Hormone
Releasing Hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6
months
We found this trial at
1
site
H. Lee Moffitt Cancer Center & Research Institute
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Julio Pow-Sang, M.D.
Phone: 813-745-2629
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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