N/A N=6 Treatment

Focal Prostate Radio-Frequency Ablation

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02328807 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) — 3; 2; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Radio-Frequency Ablation (RFA) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)	3; 2; 1	—
SECONDARY Number of Participants With Treatment Related Adverse Events	—	—
SECONDARY Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months	20.66; 13; 4.66; 9; 2.33; 1.16	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02328807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.