Focal Prostate Radio-Frequency Ablation

Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Radio-Frequency Ablation (RFA)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radio-Frequency Ablation (RFA); Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.

Procedure: Radio-Frequency Ablation (RFA); 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.; Other Names: ENCAGE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	6 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Trod Medical N.V.
• Investigators: Principal Investigator: Julio Pow-Sang, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2014
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: radiotherapy; adenocarcinoma; prostate; ENCAGE™; focal bipolar radiofrequency ablation; radiofrequency ablation (RFA)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MCC-17753

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No