Pilot Study on Focal Prostate Radio-Frequency Ablation

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.

Key facts

Study ID

NCT01423006

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

5

Starts

2011-08-01

Expected to finish

2013-03-01

Last updated by the study team

2013-11-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
• No prior treatment for prostate cancer including hormonal therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Prostate Cancer Clinical Stage T1c
• prostate-specific antigen (PSA) <10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
• Prostate size <60 cc on transrectal ultrasound
• If on anti-coagulation medications, must be able to suspend this therapy for a couple of weeks
• Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer Center review)
• Minimum of 10 biopsy cores
• No biopsy Gleason grade 4 or 5
• Unilateral cancer (only right-sided or left-sided, not bilateral)
• No more than 50% cancer in any one biopsy core
• No more than 25% of cores containing cancer

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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