In order to qualify for this clinical trial, the patient must meet the following requirements: - subjects with initial presentation of organ confined recurrent prostate cancer (Stages T1c and T2 only) who have been treated with EBRT (conventional, 3D conformal, or IMRT) or proton therapy, two or more years prior, and currently have biopsy proven local recurrence. Previous radiation therapy must be a documented therapeutic dose of 60 to 81Gy or GyE (gray equivalent) for proton therapy;
- negative bone scan within 3 months prior to enrollment to rule out possibility of metastases;
- negative CT scans of the chest, abdomen, and pelvis within 3 months prior to enrollment to rule out possibility of metastases;
- age ≥40 years through ≤85 years of age;
- prostate biopsy with >10 core biopsies demonstrating 1 or more cores positive for cancer cells, within 6 months prior to treatment;
- prostate volume ≤ 40 gms(cc) (HIFU subject prostate volume will be initially calculated utilizing TRUS measurements during screening and verified with the use of the Sonablate before initiating the HIFU procedure. Patients with prostate volumes greater than 40 gm(cc) as determined by either measurement will not be enrolled in the study);
- AP diameter of the prostate must be < 4.0 cm;
- serum prostate specific antigen (PSA) ≥0.5 ng/mL and ≤10 ng/mL;
- > 90 days post hormone therapy usages, subjects who have had or are currently undergoing hormone therapy (GnRH agonist/antagonist) must discontinue hormone therapy and go through a 90 day washout period prior to consideration for study participation, and must remain off hormone therapy throughout the duration of the follow-up period (5 years);
- signed informed consent for the HIFU treatment through the 12 month follow-up visit (7 visits) and then through the extended follow-up period of 5 years (4 additional visits);
- life expectancy > 12 months.
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