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IP/OP RSH PRO00038180 PRATH JANX007 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  JANX007, PROSTATE, PRO00038180

Screening (Day –28 to Day –1)	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Treatment Conditions - Research
  	TREATMENT CONDITIONS 37	Interval: --	Occurrences: --	Comments:	After consenting, subjects must meet the following parameters:
·        Histologically or cytologically confirmed adenocarcinoma of the prostate
·        Serum testosterone <50ng/d: achieved by orchiectomy or ongoing luteinizing hormone-releasing hormone within 28 days prior to the start of study drug
·        PSA progression: PSA level >=1ng/ml that has increased on at least 2 successive occasions at least 1 week apart
·        ANC>=1500/mm³or >=1.5X10/L
·        HGB >=9d/dL
·        PLT >=75,000/mm³
·        GFR >=45mL/min
·        Total serum bilirubin <=1.5XULN
·        AST and ALT <=2.5XULN
·        Serum albumin >=30ng/mL
·        Resting O2 >=92% ORA
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical examination
to be performed by Principal Investigator or Sub-Investigator
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	12 lead EKG
			Cardiology
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	HEMATOLOGY & CHEMISTRY  MUST BE OBTAINED WITHIN 14 DAYS PRIOR TO CYCLE 1 DAY 1
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --		  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	EPSTEIN-BARR VIRUS (EBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --			Nursing Orders
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	FOR NEUROLOGICAL DEFICITS ONLY
		  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	FOR NEUROLOGICAL DEFICITS ONLY
			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PSMA-PET and Optional FDG-PET
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	COVID-19 Optional Vaccination 
Subjects are encouraged to get the COVID-19 vaccination/booster >2 weeks prior to JANX007 treatment initiation. Vaccination efficacy on-study is unknown; however, COVID-19 vaccination would be allowed on study, after clearance of the first cycle, and with a 2-week dose hold.