title: Evaluation and follow-up of patients with N1-3 M0 or NXM1 prostate cancer in phase III trials.
abstract: OBJECTIVE
  The aim of this discussion is to review the design and conduct of phase III trials in metastatic prostate cancer, to seek ways of improving their study design, accuracy, relevance to clinical practice, acceptability to patients, and ease of participation by clinicians. We also aim to try to set uniform definitions for the evaluation of the different endpoints used in clinical trials on metastasized prostate cancer.
  
  
  METHODS
  The work was started by correspondence between the participants in the group for the year before the consensus meeting. Two comprehensive questionnaires were circulated and the answers were distributed to all the members of the group. The statements were finalized during the consensus meeting.
  
  
  RESULTS
  There were some differing opinions concerning the methods of evaluation of endpoints for follow-up, such as time to tumor progression and time to treatment failure. After the consensus conference, there were no major disagreements within the group.
  
  
  CONCLUSIONS
  The aim of phase III trials is to influence clinical management. To obtain a credible result they require a sound statistical basis with appropriate power and encompassing patients from small urologic practices as well as large or academic institutions. However, deviation from routine practice may affect the accrual rate, and the trial procedure should therefore be as similar as possible to routine management. Trials inevitably involve extra work and cost. Both should be kept to a minimum to encourage participation and hasten a timely conclusion. It is mandatory to create uniform ways of designing and evaluating clinical trials in prostate cancer.
authors.affiliation: Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, Northumberland, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Hall
authors.forename: P O
authors.initials: PO
authors.lastname: Hedlund
authors.forename: R
authors.initials: R
authors.lastname: Ackermann
authors.forename: N
authors.initials: N
authors.lastname: Bruchovsky
authors.forename: O
authors.initials: O
authors.lastname: Dalesio
authors.forename: F
authors.initials: F
authors.lastname: Debruyne
authors.forename: G P
authors.initials: GP
authors.lastname: Murphy
authors.forename: M K
authors.initials: MK
authors.lastname: Parmar
authors.forename: M
authors.initials: M
authors.lastname: Pavone-Macaluso
authors.forename: M
authors.initials: M
authors.lastname: Ruutu
authors.forename: P
authors.initials: P
authors.lastname: Smith
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000706:statistics & numerical data; D018450:Disease Progression; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D015996:Survival Rate