Focal Prostate Radio-Frequency Ablation

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02328807

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

6

Starts

2014-12-29

Expected to finish

2021-07-08

Last updated by the study team

2021-08-06

Who can join

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

You may qualify if…

• 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).

You may not qualify if…

• 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

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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