Prostate CancerNCT02328807

Focal Prostate Radio-Frequency Ablation

A study testing Radio-Frequency Ablation (RFA) in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. 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)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 29 Dec 2014to 8 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Men 18 years of age or older
Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
No prior treatment for prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
Prostate Cancer Clinical Stage T2a and below
PSA <10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy)
Prostate size <60 cc on transrectal ultrasound
Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral).

Who cannot join

Men less than 18 years of age
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

Other trials in United States

About this study

Official title: Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

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.

Conditions: Prostate Cancer
Being tested: Radio-Frequency Ablation (RFA)
Keywords: adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy
Medical subject headings: Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radio-Frequency Ablation (RFA)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 groups in NCT02328807
Study group	Role	What they receive
Radio-Frequency Ablation (RFA)	Experimental	Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months. Receives: Procedure: Radio-Frequency Ablation (RFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Number of Participants With Treatment Related Adverse Events
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.
Measured: Up to 9 months
Completion of Quality of Life (QOL) Assessment Questionnaires at Six 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. 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)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Dec 20148 Jul 2021

First posted31 Dec 2014 (estimated)
Study start29 Dec 2014
Primary completion10 May 2018
Study completion8 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
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: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02328807
Sponsor's protocol ID: MCC-17753
Status last verified: Aug 2021
First submitted: 29 Dec 2014
Last updated: 6 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
ClinicalTrials.gov ID: NCT02328807
Acronym / sponsor ID: MCC-17753
Conditions: Prostate Cancer
Keywords: adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Collaborators: Trod Medical N.V.
Study start: 29 Dec 2014 (actual)
Primary completion: 10 May 2018 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 31 Dec 2014 (estimated)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radio-Frequency Ablation (RFA)	Experimental	Procedure: 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men 18 years of age or older
Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
No prior treatment for prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
Prostate Cancer Clinical Stage T2a and below

Key exclusion criteria (5 listed)

Men less than 18 years of age
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)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	Radio-Frequency Ablation (RFA)

Primary outcome

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

2 secondary outcomes

Number of Participants With Treatment Related Adverse Events
Time frame: Up to 9 months
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra	6	6

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

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n = 6
Negative biopsy	3
Recurrence at the ablated area	2
Positive biopsy in non-treated contralateral side	1

Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra: Negative biopsy rate at 6 months after R: 0.667 (95% CI 0.223 to 0.957)

Population analysed: All participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Limitations and caveats (from the sponsor): Accrual ended prior to reaching the study goal due to equipment needing repairs.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

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) 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 8 inclusion and 5 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 6 Aug 2021. 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?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328807.

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 6 Aug 2021.