Prostate Cancer
Conditions
Keywords
Pilot, Ablation, Low Risk, Radio Frequency, RFA, minimally invasive, prostate gland
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.
Detailed description
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. Use of an RFA device was approved by the Food and Drug Association (FDA) in 1997 for the purposes of treating soft tissue tumors. The device we (Moffitt Cancer Center) will be using in this study has clearance for clinical use from the FDA. The effectiveness of the device is measured using biopsy cores at the site of the cancer after the RFA procedure. To evaluate the benefits of this procedure, we will also evaluate the change in quality-of-life indicators from baseline to 6 months following RFA. RFA is being developed as a minimally invasive potential treatment for prostate cancer. This research study is a pilot clinical trial. Pilot clinical trials are smaller versions of larger studies that are conducted to prepare for the larger study. This pilot study pre-tests a research device before a large-scale multicenter study is launched. The specific purpose of this pilot trial is to find out if RFA can effectively treat prostate cancer with fewer side effects including effects on urination, bowel function, and sexual function. RFA for early stage prostate cancer is designed to affect only the part of the prostate where cancer has been detected. The reasoning for this approach is the smaller the area given RFA, the less damage to surrounding tissues.
Interventions
PROCEDURERadio-Frequency Ablation (RFA) ENCAGE™
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.
Sponsors
Trod Medical, US,LLC
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Prostate Biopsy Rate at Six Months | 6 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | 6 Months | Patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urologic (AUA), Rectal Assessment Scale (RAS), and Sexual Health Inventory for Men (SHIM) questionnaires at baseline, 3 month and 6 month visits. QOL will be primarily based on the EPIC, developed to measure health related QOL among men with prostate cancer. |
Countries
United States
Outcome results
None listed