title: Prospective evaluation of selection criteria for active surveillance in Japanese patients with stage T1cN0M0 prostate cancer.
abstract: OBJECTIVE
  Selection criteria for active surveillance (AS) program of localized prostate cancer remain to be standardized. The purpose was to evaluate the validity of selection criteria and investigate the feasibility of this AS program.
  
  
  METHODS
  Patients meeting the criteria (i) stage T1cN0M0, (ii) age 50-80, (iii) serum prostate-specific antigen (PSA) </=20 ng/ml, (iv) one or two positive cores per 6-12 systematic biopsy cores, (v) Gleason score </=6, and (vi) cancer involvement in positive core </=50% were enrolled and encouraged to start AS for at least 6 months during the period between January 2002 and December 2003. PSA was measured bimonthly for 6 months and every 3 months thereafter. Trigger of treatment recommendation was PSA-doubling time (PSADT) of </=2 years or pathological progression at re-biopsy. Primary endpoint was '%PSADT > 2y', which was defined as the proportion of patients who showed PSADT assessed at 6 months >2 years out of all the patients who chose AS. Point estimate of '%PSADT > 2y' was expected to be >80%.
  
  
  RESULTS
  One hundred and eighteen patients opted for AS and 16 chose immediate treatment at enrollment. PSADT for the initial 6 months based on four measurements could be assessed in 106 patients. Intent-to-treat analysis of '%PSADT > 2y' was 71.2% (84/118, 95% CI: 62.1-79.2). Pathological progression rate at 1-year re-biopsy was 33%. Fifty-four (46%) patients remained on AS for maximal observation of 54 months. General health-related QOL in patients undergoing AS was not impaired.
  
  
  CONCLUSIONS
  The primary endpoint, '%PSADT > 2y', did not meet the pre-specified decision criteria. Further prospective study with revised program and endpoint is needed.
authors.affiliation: Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan. kakehi@med.kagawa-u.ac.jp
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kakehi
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kamoto
authors.forename: Taizou
authors.initials: T
authors.lastname: Shiraishi
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Suzukamo
authors.forename: Shunichi
authors.initials: S
authors.lastname: Fukuhara
authors.forename: Yuko
authors.initials: Y
authors.lastname: Saito
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Tobisu
authors.forename: Tadao
authors.initials: T
authors.lastname: Kakizoe
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Koichiro
authors.initials: K
authors.lastname: Akakura
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Suzuki
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.forename: Shin
authors.initials: S
authors.lastname: Egawa
authors.forename: Akira
authors.initials: A
authors.lastname: Irie
authors.forename: Takefumi
authors.initials: T
authors.lastname: Sato
authors.forename: Osamu
authors.initials: O
authors.lastname: Maeda
authors.forename: Norio
authors.initials: N
authors.lastname: Meguro
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Sumiyoshi
authors.forename: Takanori
authors.initials: T
authors.lastname: Suzuki
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Shimizu
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Arai
authors.forename: Akito
authors.initials: A
authors.lastname: Terai
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kato
authors.forename: Tomonori
authors.initials: T
authors.lastname: Habuchi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujimoto
authors.forename: Masashi
authors.initials: M
authors.lastname: Niwakawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D006304:Health Status; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D011159:Population Surveillance / Q000379:methods*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000276:immunology / Q000473:pathology* / Q000517:prevention & control*; D011788:Quality of Life
chemical_list: D017430:Prostate-Specific Antigen