Focal Prostate Radio-Frequency Ablation

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328807
• Other study ID #: MCC-17753
• Status: Completed
• Phase: N/A
• Start date: December 29, 2014
• Est. completion date: July 8, 2021

Study information

• Verified date: August 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 8, 2021
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Trod Medical N.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trials website