Focal Prostate Radio-Frequency Ablation

H. Lee Moffitt Cancer Center and Research Institute6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Radio-Frequency Ablation (RFA)PROCEDURE

RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)

The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method.

Time frame: 6 months

Secondary Outcomes

Number of Participants With Treatment Related Adverse Events

The type of event using NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 will be identified and graded for severity. The relationship of the adverse event to the therapy or procedure will be determined as follows: Unrelated; Unlikely; Possible; Probable; Definite. For reporting purposes, an adverse event is considered unexpected when either the type of event or severity of the event is not listed in the study consent.

Time frame: Up to 9 months

Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months

The secondary objective is to evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. The patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA), Rectal Assessment Scale (RAS), and International Index of Erectile Function (IIEF-5) questionnaires at baseline and 6-month visit. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits)

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.