title: Long-term results of a phase II trial of ultrasound-guided radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (RTOG 98-05).
abstract: OBJECTIVE
  To evaluate the long-term effectiveness of transrectal ultrasound-guided permanent radioactive I125 implantation of the prostate for organ confined adenocarcinoma of the prostate compared with historical data of prostatectomy and external beam radiotherapy within a cooperative group setting.
  
  
  METHODS
  Patients accrued to this study had histologically confirmed, locally confined adenocarcinoma of the prostate clinical stage T1b, T1c, or T2a; no nodal or metastatic disease; prostate-specific antigen level of ≤10 ng/ml; and a Gleason score of ≤6. All patients underwent transrectal ultrasound-guided radioactive I125 seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume.
  
  
  RESULTS
  A total of 101 patients from 27 institutions were accrued to this protocol; by design, no single institution accrued more than 8 patients. There were 94 eligible patients. The median follow up was 8.1 years (range, 0.1-9.2 years). After 8 years, 8 patients had protocol-defined biochemical (prostate-specific antigen) failure (cumulative incidence, 8.0%); 5 patients had local failure (cumulative incidence, 5.5%); and 1 patient had distant failure (cumulative incidence, 1.1%; this patient also had biochemical failure and died of causes not related to prostate cancer). The 8-year overall survival rate was 88%. At last follow-up, no patient had died of prostate cancer or related toxicities. Three patients had maximum late toxicities of Grade 3, all of which were genitourinary. No Grade 4 or 5 toxicities were observed.
  
  
  CONCLUSIONS
  The long-term results of this clinical trial have demonstrated that this kind of trial can be successfully completed through the RTOG and that results in terms of biochemical failure and toxicity compare very favorably with other brachytherapy published series as well as surgical and external beam radiotherapy series. In addition, the prospective, multicenter design highlights the probable generalizability of the outcomes.
authors.affiliation: Radiation Oncology Medical College of Wisconsin, Milwaukee, WI 53226, USA. clawton@mcw.edu
authors.forename: Colleen A
authors.initials: CA
authors.lastname: Lawton
authors.forename: Daniel
authors.initials: D
authors.lastname: Hunt
authors.forename: W Robert
authors.initials: WR
authors.lastname: Lee
authors.forename: Leonard
authors.initials: L
authors.lastname: Gomella
authors.forename: David
authors.initials: D
authors.lastname: Grignon
authors.forename: Michael
authors.initials: M
authors.lastname: Gillin
authors.forename: Gerard
authors.initials: G
authors.lastname: Morton
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Pisansky
authors.forename: Howard
authors.initials: H
authors.lastname: Sandler
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D015996:Survival Rate; D018084:Ultrasonography, Interventional
chemical_list: D007457:Iodine Radioisotopes; D017430:Prostate-Specific Antigen