Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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.

Radio-Frequency Ablation (RFA)

Julio Pow-Sang, M.D.

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.

Focal Prostate Radio-Frequency Ablation

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

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.

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.

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)

Trod Medical N.V.

H. Lee Moffitt Cancer Center and Research Institute

Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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

Dr. Julio M. Pow-Sang

This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.

Negative biopsy

Recurrence at the ablated area

Positive biopsy in non-treated contralateral side

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

Number of Participants With Treatment Related Adverse Events

SHIM score

AUA score

RAS score

EPIC score - Overall Satisfaction

Quality of Life Assessments prior to focal Prostate Radio-Frequency Ablation (RFA).

Spots Global Cancer Trial Database for Focal Prostate Radio-Frequency Ablation

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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