Trial Outcomes & Findings for Focal Prostate Radio-Frequency Ablation (NCT NCT02328807)

NCT ID: NCT02328807

Last Updated: 2021-08-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-08-06

Participant Flow

Six participants were enrolled at Moffitt Cancer Center, August 2015 through July 2017.

Participant milestones

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Focal Prostate Radio-Frequency Ablation

Baseline characteristics by cohort

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n=6 Participants Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Age, Continuous	54.66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants.

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.

Outcome measures

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n=6 Participants Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.	Quality of Life Assessments - After RFA Quality of Life Assessments after focal Prostate Radio-Frequency Ablation (RFA)
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) Negative biopsy	3 Participants	—
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) Recurrence at the ablated area	2 Participants	—
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) Positive biopsy in non-treated contralateral side	1 Participants	—

SECONDARY outcome

Timeframe: Up to 9 months

Population: All participants.

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.

Outcome measures

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n=6 Participants Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.	Quality of Life Assessments - After RFA Quality of Life Assessments after focal Prostate Radio-Frequency Ablation (RFA)
Number of Participants With Treatment Related Adverse Events	0 Participants	—

SECONDARY outcome

Timeframe: 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. 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)

Outcome measures

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n=6 Participants Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.	Quality of Life Assessments - After RFA n=6 Participants Quality of Life Assessments after focal Prostate Radio-Frequency Ablation (RFA)
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months SHIM score	20.66 score on a scale Interval 11.0 to 24.0	13 score on a scale Interval 5.0 to 20.0
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months AUA score	4.66 score on a scale Interval 1.0 to 9.0	9 score on a scale Interval 4.0 to 19.0
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months RAS score	2.33 score on a scale Interval 1.0 to 4.0	1.16 score on a scale Interval 0.0 to 3.0
Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months EPIC score - Overall Satisfaction	3.8 score on a scale Interval 3.0 to 5.0	3.5 score on a scale Interval 1.0 to 5.0

Adverse Events

Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra n=6 participants at risk Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months.
Renal and urinary disorders Hematuria	33.3% 2/6 • Number of events 2 • 2 years
Reproductive system and breast disorders Other - Blood in semen	16.7% 1/6 • Number of events 1 • 2 years
Renal and urinary disorders Urinary tract pain	16.7% 1/6 • Number of events 1 • 2 years
General disorders Fever	16.7% 1/6 • Number of events 1 • 2 years
Renal and urinary disorders Urinary frequency	33.3% 2/6 • Number of events 2 • 2 years
Renal and urinary disorders Urinary urgency	33.3% 2/6 • Number of events 2 • 2 years
Reproductive system and breast disorders Erectile dysfunction	50.0% 3/6 • Number of events 3 • 2 years
Musculoskeletal and connective tissue disorders Other - sciatica	16.7% 1/6 • Number of events 2 • 2 years
Reproductive system and breast disorders Other - prostate sensitivity	16.7% 1/6 • Number of events 1 • 2 years
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • 2 years
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • 2 years
General disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 1 • 2 years
Renal and urinary disorders Renal and urinary disorders - Other, nocturia	16.7% 1/6 • Number of events 1 • 2 years
Infections and infestations Sinuusitis	16.7% 1/6 • Number of events 1 • 2 years
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • 2 years
Renal and urinary disorders Renal and urinary disorders - Other Dysuria	16.7% 1/6 • Number of events 2 • 2 years
Renal and urinary disorders Renal and urinary disorders - Other, Burning sensation while urinating	16.7% 1/6 • Number of events 1 • 2 years

Additional Information

Dr. Julio M. Pow-Sang

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-2226

Email: julio.powsang@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place