Prostate Cancer
Conditions
Keywords
adenocarcinoma, prostate, ENCAGE™, focal bipolar radiofrequency ablation, radiofrequency ablation (RFA), radiotherapy
Brief 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.
Interventions
PROCEDURERadio-Frequency Ablation (RFA)
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 N.V.
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
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | Up to 9 months | 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. |
| Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | 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) |
Countries
United States
Participant flow
Recruitment details
Six participants were enrolled at Moffitt Cancer Center, August 2015 through July 2017.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra |
|---|---|
| Age, Continuous | 54.66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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.
Time frame: 6 months
Population: All participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | Negative biopsy | 3 Participants |
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | Recurrence at the ablated area | 2 Participants |
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | Positive biopsy in non-treated contralateral side | 1 Participants |
Comparison: This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.95% CI: [0.223, 0.957]
Secondary
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)
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | SHIM score | 20.66 score on a scale |
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | AUA score | 4.66 score on a scale |
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | RAS score | 2.33 score on a scale |
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | EPIC score - Overall Satisfaction | 3.8 score on a scale |
| Quality of Life Assessments - After RFA | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | EPIC score - Overall Satisfaction | 3.5 score on a scale |
| Quality of Life Assessments - After RFA | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | SHIM score | 13 score on a scale |
| Quality of Life Assessments - After RFA | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | RAS score | 1.16 score on a scale |
| Quality of Life Assessments - After RFA | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | AUA score | 9 score on a scale |
Secondary
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.
Time frame: Up to 9 months
Population: All participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Number of Participants With Treatment Related Adverse Events | 0 Participants |