Status:
COMPLETED
Pilot Study on Focal Prostate Radio-Frequency Ablation
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Trod Medical, US,LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01423006
Start Date
August 1 2011
End Date
March 1 2013
Last Update
November 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612