Focal Prostate Radio-Frequency Ablation

NCT02328807 | Completed Results DMC

• 1 other identifier: MCC-17753
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma; prostate; ENCAGE™; focal bipolar radiofrequency ablation; radiofrequency ablation (RFA); radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Treatment Related Adverse Events

  Up to 9 months

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

  6 months

Study Arms (1)

Radio-Frequency Ablation (RFA)

EXPERIMENTAL

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)

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.

Also known as: ENCAGE™

Radio-Frequency Ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Men less than 18 years of age
• Medically unfit for anesthesia
• Histology other than adenocarcinoma
• Men who have received any hormonal manipulation (antiandrogens; Luteinizing Hormone Releasing Hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Trod Medical N.V.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Accrual ended prior to reaching the study goal due to equipment needing repairs.

Results Point of Contact

• Title: Dr. Julio M. Pow-Sang
• Organization: H. Lee Moffitt Cancer Center and Research Institute

julio.powsang@moffitt.org

813-745-2226

Study Officials

• Julio Pow-Sang, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: December 29, 2014
• Primary Completion: May 10, 2018
• Study Completion: July 8, 2021
• Last Updated: August 6, 2021
• Results First Posted: June 3, 2019

Record last verified: 2021-08

Locations

US (1)