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OP RESEARCH PRO00035089 / EFSTATHIOU XL184-315 RANDOMIZED PHASE 3 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  CABOMETYZ, TECENTRIQ, PROSTATE, SCREENING

Screening (<= 28 Days)	Repeat 1 time	Cycle length: 7 days	Day -28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed Consent must be obtained prior to any study related assessments or procedures.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics, Medical and Cancer history
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Documentation on Analgesic Use
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Record Concomitant Medications and Adverse Events (SAEs and AESIs from time of Consent).
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Archival Tissue, if available.  If Archival Tissue is unavailable, schedule for fresh tumor biopsy prior to first dose of treatment.
			Imaging
◉	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◉	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or MRI
		◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or MRI
		◯	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or MRI
		◯	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or CT
		◯	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or CT
		◯	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Assessment, if clinically indicated; Or CT
			Imaging
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Perform bone CT if clinically indicated.
			Nuclear Medicine
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Technetium
					
Screening (<= 21 Days)	Repeat 1 time	Cycle length: 21 days	Day -21	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Heart Rate, Respiratory Rate, Temperature, Blood Pressure
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ZZEOSINOPHIL SMEAR	Interval: --	Occurrences: --		  	HEMATOCRIT	Interval: --	Occurrences: --		  	HEMOGLOBIN & HEMATOCRIT	Interval: --	Occurrences: --		  	PLATELET COUNT	Interval: --	Occurrences: --		  	RED CELL BLOOD COUNT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Within 24 hours prior to dosing.
		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --	Comments:	Within 24 hours prior to dosing.
		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 24 hours prior to dosing.
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Within 24 hours prior to dosing.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	PROTEIN, URINALYSIS	Interval: --	Occurrences: --	Comments:	Spot urine; fully quantitative
		  	URINE PROTEIN/CREATININE RATIO, RANDOM	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Collect 24-hour urine (at the discretion of the Investigator based on increases in UPCR).
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	With reflex testing of HCV RNA if antibody test is positive at screening
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --