Focal Prostate Radio-Frequency Ablation

H. Lee Moffitt Cancer Center and Research Institute

Status

Completed

Conditions

Prostate Cancer

Treatments

Procedure: Radio-Frequency Ablation (RFA)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02328807

MCC-17753

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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