title: HIFU as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer after radical prostatectomy: a pilot study.
abstract: OBJECTIVE
  To test high-intensity focused ultrasound (HIFU) as salvage first-line treatment for palpable, TRUS-evidenced, biopsy-proven locally recurrent prostate cancer (CaP) after radical prostatectomy (RP).
  
  
  METHODS
  Nineteen patients with palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP after RP, unwilling to undergo salvage radiotherapy (SRT), underwent HIFU as a single-session procedure. Pre-, intra-, and postoperative data including early and late complications, and oncologic outcomes (PSA nadir, biochemical recurrence (BCR)-free survival, and need of secondary adjuvant treatment) were prospectively evaluated. Success was defined as PSA nadir ≤0.1 ng/ml obtained within 3 months from HIFU. In case of PSA nadir >0.1 ng/ml or PSA increase ≥1 ng/ml above the PSA nadir, a biopsy of the treated lesion was performed, and if negative, maximum androgen blockade (MAB) was adopted. In case of positive biopsy, RT was performed. Failure was defined as use of secondary adjuvant treatment (MAB or RT).
  
  
  RESULTS
  Median follow-up was 48 months. All cases were performed as overnight procedure. No case of urethrorectal fistula or anastomotic stricture was observed. Two cases of acute urinary retention were resolved with prolonged urethral catheterization. Four cases of stress urinary incontinence were observed; 2 (mild incontinence) were resolved after pelvic floor exercises within 6 months, while 2 cases of severe incontinence required surgical minimally invasive treatment;17/19 patients (89,5%) were classified as success. Two patients failed to show a PSA nadir <0.1 ng/ml. During follow-up, 8/17 patients (47%) were classified as failure, with consequent total rate of failures 10/19 (52.6%). A statistically significant difference was observed in pre-HIFU median PSA (2 vs. 5.45 ng/ml, respectively, P = 0.013) and Gleason score of the RP specimen (P = 0.01) between the success and failure group.
  
  
  CONCLUSIONS
  Salvage first-line HIFU for palpable, TRUS-evidenced, biopsy-proven local recurrence of CaP is a feasible, minimally invasive day-case procedure, with an acceptable morbidity profile. It seems to have a good cancer control in the short- and mid-term. Patients with lower pre-HIFU PSA level and favorable pathologic Gleason score presented better oncologic outcomes. A prospective randomized trial with an adequate recruitment and follow-up is necessary to confirm our preliminary oncologic results.
authors.affiliation: Division of Urology, Department of Surgery, Fondazione Policlinico Tor Vergata, University of Tor Vergata, Rome, Italy. tasospao2003@yahoo.com
authors.forename: Anastasios D
authors.initials: AD
authors.lastname: Asimakopoulos
authors.forename: Roberto
authors.initials: R
authors.lastname: Miano
authors.forename: Guido
authors.initials: G
authors.lastname: Virgili
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vespasiani
authors.forename: Enrico
authors.initials: E
authors.lastname: Finazzi Agrò
mesh_terms: D000368:Aged; D001706:Biopsy; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010865:Pilot Projects; D011467:Prostate / Q000473:pathology / Q000601:surgery; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000379:methods; D011471:Prostatic Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D016879:Salvage Therapy / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D036761:Ultrasound, High-Intensity Focused, Transrectal / Q000379:methods*
chemical_list: D017430:Prostate-Specific Antigen