Acceptance Criteria

What studies meet the Prostate Cancer Treatment Comparison Study Acceptance Criteria?

Prostate Cancer Treatment Comparison Study Acceptance Criteria

The Prostate Cancer Treatment Comparison Study is updated twice a year. New papers are reviewed on a continuous basis, and those paper in line with the acceptance criteria are included in the update. Published papers included in the Prostate Cancer Treatment Comparison Study, must meet the acceptance criteria established by the Prostate Cancer Results Study Group.

Study Acceptance Criteria

  1. Patients must be stratified into recognizable Pre-Treatment Risk Groups: Low, Intermediate, and High Risk by either D’Amico, Zelefsky or NCCN stratification. The risk group must be maintained after treatment.
  2. A biochemical (PSA) result must be reported by standard means recognizable and comparable.
  3. BRFS (biochemical relapse free survival)* standard endpoint ASTRO, Phoenix, and PSA < 0.2 (surgery).
  4. Patients must be clinically staged** pre-treatment.
  5. No exclusions. I.E. No Pathologic staging. In other words after surgery the surgeon could not eliminate or exclude a patient from future analysis because of an unfavorable feature, such as positive margin or positive lymph nodes.
  6. External doses must be modern doses. Minimum 72 Gy*** IMRT/conformal.
  7. All treatment modalities must be considered; Seeds, Surgery, IMRT, HIFU, CRYO, Protons and/or HDR.
  8. Only peer reviewed journals are included. Peer reviewed journals are those in which every article is first reviewed by an expert panel before publication.
  9. An adequate number of patients must be included. Low Risk Accepted minimum number 100 patients. Intermediate Risk Accepted minimum number 100 patients. High Risk Accepted minimum number 50 patients.
  10. Minimum median follow up: 5 yr. This is to insure that patients were followed long enough to adequately evaluate the results long-term.

* BRFS Biochemical Relapse Free Survival: As standard form of measuring results of treatment. It reports on whether a patient has failed by PSA criteria. It does not indicate merely patient survival, it represents the less-stringent criteria of a non-rising PSA. Common methods use a rising PSA on 2 or three consecutive occasions to define a failure.

** Stage: The definition of the size and extent of a cancer at a particular point in time. Usually cancers are staged using the T (tumor) N (nodes) M metastasis) staging system. T1a, b, c , T2a,b,c T3 are examples of stages. Older systems using A, B, C, D are rarely used and usually not helpful in deciding treatment. Current prostate cancer staging does not include PSA and Gleason scoring. Defining ones prognosis or recommending a particular course of therapy based on stage alone should not be done. Risk group classifications were developed which include stage, PSA and Gleason score information and are better at evaluating treatment outcomes.

*** Gy – Gray: A unit of measuring radiation. Typical external doses are 75-80 Gy. Implant doses range from 90-160 Gy. May also sometimes be recorded as cGY centigray which is a 1000 Grays.