J R Stat Soc Ser C Appl Stat 2009;58(2):211-24. Revised Protocol No.: 04 Date: 31-May-2019 220 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS APPENDIX 11 PROSTATE CANCER WORKING GROUP 3 (PCWG3) GUIDELINES (WITH MODIFIED RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) CRITERIA FOR SOFT TISSUE LESION ASSESSMENT) 1 EVALUATION OF LESIONS Bone lesions s hould be evaluated with Technecium-99m based radionuclide bone scan as per PCWG31. At baseline, soft tissue lesions/lymph nodes will be categorized as measurable or non-measurable as follows. 1.1 Measurable Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: 10 mm by CT/MRI scan (scan slice thickness no greater than 5 mm), or ≥2x slice thickness if greater than 5mm. Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be≥15 mm in short axis when assessed by CT/MRI scan (scan slice thickness recommended to be no greater than 5 mm). Lymph nodes merit special mention since they are normal anatomical structures which may be visible by imaging even if not involved by tumor. Pathological nodes which are defined as measurable and may be identified as target lesi ons must meet the criterion of a short axis of ≥15 mm by CT/MRI scan. Only the short axis of these nodes will contribute to the baseline sum. The short axis of the node is the diameter normally used by radiologists to j udge if a node is involved by solid tumor. Nodal size is normally re ported as two dimensions in the plane in which the image is obtained (for CT scan this is almost always the axial plane; for MRI the plane of acquisition may be axial, sagittal or coronal). The smaller of these measures is the short axis. For example, an abdominal node which is reported as being 20 mm x 30 mm has a short axis of 20 mm and qualifies as a malignant, measurable node. In this example, 20 mm should be recorded as the node measurement. All other pathol ogical nodes (those with short axis ≥ 10 mm but < 15 mm) should be considered non-target lesions. Nodes that have a short axis < 10 mm are considered non-pathological and should not be recorded or followed. Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.1.2 Non-Measurable All other soft tissue lesions are considered non-measurable, including small lesions (longest diameter < 10mm or pathol ogical lymph nodes with ≥10 to < 15 mm short axis) as well as truly non-measurable lesions. Lesions considered truly non-measurable include: leptomeningeal disease, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques. Revised Protocol No.: 04 Date: 31-May-2019 221 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions. 1.3 Special considerations regarding bone lesions Bone lesions will be assessed with Technecium-99m based radionuclide bone scans as per PCWG3. 1.4 Baseline Documentation Of ‘Target’ And ‘Non-Target’ LesionsWhen more than one measurable lesion is present at baseline all lesions up to a maximum of 20 lesions total (and a maximum of 5 lesions per organ system) representative of all involved organs should be identified as target lesion s and will be recorded and measured at baseline. Note: A maximum of 5 lesions can be selected per organ system.