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TABLE 1. Prostate Cancer Working Group 2 Criteria Regarding
Progression for Clinical Trial Eligibility by Disease Manifestation
VARIABLE CRITERIA
PSA
  • Obtain sequence of rising values at a minimum of 1-week intervals
  • Must report minimum starting value of 2.0 ng/mL
  • Estimate pre-therapy PSA-DT if ≥ 3 values are available ≥ 4 weeks apart
Target lesions
  • Nodal or visceral progression is sufficient for trial entry independent of PSA
  • Measurable lesions are not required for entry
  • Use RECIST to record soft-tissue (nodal and visceral) lesions as target or nontarget
  • Lymph nodes ≥ 2 cm in diameter only should be used to assess for a change in size
  • The presence of nodal and/or visceral disease should be recorded separately
Prostate/prostate bed
  • Record prior treatment of primary tumor
  • Perform directed pelvic imaging (eg, CT, MRI, PET/CT, endorectal MRI, transrectal ultrasound) to document the presence or absence of disease
Bone
  • Progression = appearance of ≥ 2 new lesions
  • Confirm ambiguous results by other imaging modalities (eg, CT or MRI)
Other sites of disease
  • Patients with treated epidural lesions and no other epidural progression are eligible

CT = computed tomography; MRI = magnetic resonance imaging; PET = positron emission tomography; PSA = prostate-specific antigen; PSA-DT = prostate-specific antigen doubling time; RECIST = Response Evaluation Criteria in Solid Tumors.
Adapted with permission from Scher HI, Halabi S, Tannock I, et al; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26(7):1148-1159.