Clinical Trial 17753

Cancer Type: Genitourinary
Interventions:

Study Type: Treatment
Phase of Study: NA
Investigators:

  • Julio Pow-Sang

Overview

Study Title

Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

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.

Objective

Primary Objective: To assess the local oncologic efficacy of focal RFA in men with unilateral, clinically localized prostate cancer as measured by the ability to obtain all negative biopsy cores at the sites of focal ablation of the cancer, "all negative" means no prostate cancer; if the biopsy contains inflammation, or pre-cancerous changes (high-grade prostatic intraepithelial neoplasia and /or atypical small acinar proliferation it will be considered negative for study purposes). Secondary Objective: To evaluate the safety of the procedure and change in quality-of-life indicators from baseline to 6 months following focal RFA in patients with localized prostate cancer. To understand and evaluate imaging characteristics of treated prostate cancer by bipolar RFA.

Inclusion Criteria

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  • 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 > Prostate size > Pre-enrollment biopsy parameters: Minimum of 10 biopsy cores; No primary pattern biopsy Gleason grade 4 or 5; Unilateral cancer (only right-sided or left-sided, not bilateral); No more than 1 core with 50% cancer; No more than 4 cores with positive biopsies with Gleason pattern 3 + 3 and no more than 2 cores with positive biopsies containing Gleason pattern 3 + 4.

  • Exclusion Criteria

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  • 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