title: Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162).
abstract: OBJECTIVE
  To establish whether absolute prostate-specific antigen (PSA) value after androgen deprivation (AD) is prognostic in metastatic (D2) prostate cancer (PCa).
  
  
  METHODS
  D2 PCa patients with baseline PSA of at least 5 ng/mL received 7 months induction AD. Patients achieving PSA of 4.0 ng/mL or less on months 6 and 7 are randomly assigned to continuous versus intermittent AD on month 8. Eligibility for this analysis required a prestudy PSA with at least two subsequent PSAs and that patients be registered at least 1 year before analysis date. Survival was defined as time to death after 7 months of AD. Associations were evaluated by proportional hazards regression models.
  
  
  RESULTS
  One thousand one hundred thirty four of 1,345 eligible patients achieved a PSA of 4 ng/mL or less. At end of induction, 965 patients maintained PSA of 4 or less and 604 had a PSA of 0.2 ng/mL or less. After controlling for prognostic factors, patients with a PSA of 4 or less to more than 0.2 ng/mL had less than one third the risk of death (ROD) as those with a PSA of more than 4 ng/mL (P < .001). Patients with PSA of 0.2 ng/mL or less had less than one fifth the ROD as patients with a PSA of more than 4 ng/mL (P < .001) and had significantly better survival than those with PSA of more than 0.2 to 4 ng/mL or less (P < .001). Median survival was 13 months for patients with a PSA of more than 4 ng/mL, 44 months for patients with PSA of more than 0.2 to 4 ng/mL or less, and 75 months for patients with PSA of 0.2 ng/mL or less.
  
  
  CONCLUSIONS
  A PSA of 4 ng/mL or less after 7 months of AD is a strong predictor of survival. This data should be used to tailor future trial design for D2 prostate cancer.
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Maha
authors.initials: M
authors.lastname: Hussain
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Tangen
authors.forename: Celestia
authors.initials: C
authors.lastname: Higano
authors.forename: Paul F
authors.initials: PF
authors.lastname: Schelhammer
authors.forename: James
authors.initials: J
authors.lastname: Faulkner
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: George
authors.initials: G
authors.lastname: Wilding
authors.forename: Atif
authors.initials: A
authors.lastname: Akdas
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Small
authors.forename: Bryan
authors.initials: B
authors.lastname: Donnelly
authors.forename: Gary
authors.initials: G
authors.lastname: MacVicar
authors.forename: Derek
authors.initials: D
authors.lastname: Raghavan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000401:mortality / Q000473:pathology; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen