Prostate CancerNCT01423006
Pilot Study on Focal Prostate Radio-Frequency Ablation
A study testing Radio-Frequency Ablation (RFA) ENCAGE™ in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radio-Frequency Ablation (RFA) ENCAGE™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radio-Frequency Ablation (RFA) ENCAGE™
- Keywords
- Pilot, Ablation, Low Risk, Radio Frequency, RFA, minimally invasive, prostate gland
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-Frequency Ablation (RFA) ENCAGE™Procedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radio-Frequency Ablation (RFA) ENCAGE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
Completion of Quality of Life (QOL) Assessment Questionnaires at Six 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Trod Medical, US,LLC
- Responsible party
- Sponsor
- Investigators
- Julio Pow-Sang, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423006
- Sponsor's protocol ID
- MCC-16584
- Status last verified
- Nov 2013
- First submitted
- 23 Aug 2011
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01423006
- Acronym / sponsor ID
- MCC-16584
- Conditions
- Prostate Cancer
- Keywords
- Pilot, Ablation, Low Risk, Radio Frequency, RFA, minimally invasive, prostate gland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Trod Medical, US,LLC
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Prostate Radio-Frequency Ablation | Experimental | Procedure: Radio-Frequency Ablation (RFA) ENCAGE™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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio-Frequency Ablation (RFA) ENCAGE™Also: 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. | Procedure or surgery | Focal Prostate Radio-Frequency Ablation |
Primary outcome
Negative Prostate Biopsy Rate at Six Months
Time frame: 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.
1 secondary outcome
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Pow-Sang, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio-Frequency Ablation (RFA) ENCAGE™ in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative Prostate Biopsy Rate at Six Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.