Focal Prostate Radio-Frequency Ablation
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|ClinicalTrials.gov Identifier: NCT02328807|
Recruitment Status : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Radio-Frequency Ablation (RFA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer|
|Actual Study Start Date :||December 29, 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
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 Name: ENCAGE™
- Negative Biopsy Rate at 6 Months [ Time Frame: 6 months ]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.
- Number of Participants with Adverse Events [ Time Frame: Up to 9 months ]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.
- Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months [ Time Frame: 6 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. The QOL will be primarily based on the EPIC, developed to measure health related quality of life among men with prostate cancer. The EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal) [Wei et al, 2000]. The EPIC summary score and subscale characteristics at each time-point will be calculated based on its scoring instruction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328807
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Julio Pow-Sang, M.D.||H. Lee Moffitt Cancer Center and Research Institute|