NCT01423006

Brief Summary

This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

August 23, 2011

Last Update Submit

November 13, 2013

Conditions

Prostate Cancer

Keywords

PilotAblationLow RiskRadio FrequencyRFAminimally invasiveprostate gland

Outcome Measures

Primary Outcomes (1)

  • Negative Prostate Biopsy Rate at Six Months

    The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. Evaluable patients for this study will be those who complete up through the six month follow-up/evaluation procedure.

    6 Months

Secondary Outcomes (1)

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

    6 Months

Study Arms (1)

Focal Prostate Radio-Frequency Ablation

EXPERIMENTAL

Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy.

Procedure: Radio-Frequency Ablation (RFA) ENCAGE™

Interventions

Radio-Frequency Ablation (RFA) ENCAGE™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™
Focal Prostate Radio-Frequency Ablation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
  • No prior treatment for prostate cancer including hormonal therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Prostate Cancer Clinical Stage T1c
  • prostate-specific antigen (PSA) \<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
  • Prostate size \<60 cc on transrectal ultrasound
  • If on anti-coagulation medications, must be able to suspend this therapy for a couple of weeks
  • Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer Center review)
  • Minimum of 10 biopsy cores
  • No biopsy Gleason grade 4 or 5
  • Unilateral cancer (only right-sided or left-sided, not bilateral)
  • No more than 50% cancer in any one biopsy core
  • No more than 25% of cores containing cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Julio Pow-Sang, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

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

August 23, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

US(1)