A single arm phase II study of bone-targeted Sn-117 m-DTPA in symptomatic castration-resistant prostate cancer with skeletal metastases

Table 3 Data Collection Schedule

	Pre-study	Cycle 1 (8 weeks or 56 days)					Cycle 2 (8 weeks or 56 days)					Post-treatment						FU^d	OSV
	Pre-study	W1	W2	W4	W6	W8	W9	W10	W12	W14	W16	W18	W20	W22	W24	W26	W28
Sn-117 m-DTPA		A					A											A
^aPain medication	X	X	X	X	X	X		X	X	X	X		X		X		X	X	X
CBC/diff, platelets	X	X	X	X	X	X		X	X	X	X		X		X		X	X	X
Serum chemistry	X	X	X	X	X	X		X	X	X	X		X		X		X	X	X
PSA	X			X		X			X		X		X		X		X	X	X
Patient-reported pain intensity scale and analgesic use^b	X		X	X	X	X		X	X	X	X	X	X	X	X	X	X	X	X
Patient-reported CTCAE^c			X	X	X	X		X	X	X	X	X	X	X	X	X	X	X	X
Urine collection for urinalysis	X	X	X	X		X			X		X		X		X		X	X

A indicates radiotherapy; FU Follow-up (every 3 months), OSV Off-Study Visit, CTCAE Common Terminology Criteria for Adverse Events, PSA Prostate-specific antigen
^aStudy coordinator/research nurse will inquire about pain medications including names, dosage and frequency; this person also is required to fill out pain medication list form during every clinic visit
^bPre-treatment daily baseline pain and analgesic use for 7 days (at least 4 out of 7 days) is required before treatment initiation. Patients will be asked to report their pain at its worst in the last 24 h, and analgesic use (stable/reduced/increased) by digital version every 2 weeks through Week 28, followed by routine clinic follow up or when they experience new pain during off-visit. A full short version of brief pain inventory (BPI) will be asked at baseline, after Cycle 1, after Cycle 2, and at Week 24
^cPRO-CTCAE survey items will be assessed by digital instruments. Beginning at Week 28, surveys are requested every 3 months for 6 months after the last study treatment administration
^dFollow-up visit evaluation. Every 3 months or as clinically indicated up to one year from the first dose injection or disease progression

ISSN: 1471-2407