N/A
Completed N=6
Focal Prostate Radio-Frequency Ablation
Source: ClinicalTrials.gov NCT02328807 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) — 3; 2; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) |
3; 2; 1 | — |
| SECONDARY Number of Participants With Treatment Related Adverse Events |
— | — |
| SECONDARY Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months |
20.66; 13; 4.66; 9; 2.33; 1.16 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02328807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.