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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02328807

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov