Table 2.

Criteria of Progression for Trial Eligibility By Disease Manifestation

Variable	PCWG1 (1999)1	PCWG2 (2007)
PSA	Obtain sequence of rising values at ≥ 1-week intervals 5.0 ng/mL minimum level for entry	Obtain sequence of rising values at a minimum of 1-week intervals 2.0 ng/mL minimum starting value Estimate pretherapy PSA-DT if 3 or more values available 4 or more weeks apart
Target lesions	Nodal or visceral site progression sufficient for trial entry independent of PSA Measurable disease not required for trial entry	Nodal or visceral progression sufficient for trial entry independent of PSA Measurable lesions not required for entry Use RECIST to record soft-tissue (nodal and visceral) lesions as target or nontarget Only lymph nodes ≥ 2 cm in diameter should be used to assess for a change in size Record presence of nodal and/or visceral disease separately
Prostate/prostate bed (primary site)	Not addressed	Record prior treatment of primary tumor Perform directed pelvic imaging (CT, MRI, PET/CT, endorectal MRI, transrectal ultrasound) to document presence or absence of disease
Bone	Not defined	Progression = appearance of 2 or more new lesions Confirm ambiguous results by other imaging modalities (eg, CT or MRI)
Other sites of disease	Not addressed	Patients with treated epidural lesions and no other epidural progression are eligible

Abbreviations: PCWG1, Prostate-Specific Antigen Working Group 1; PCWG2, Prostate Cancer Clinical Trials Working Group 2; PSA, prostate-specific antigen; PSA-DT, PSA doubling time; RECIST, Response Evaluation Criteria in Solid Tumors; CT, computed tomography; MRI, magnetic resonance imaging; PET, positron emission tomography.