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OP RSH PRO00039835 EFSTATHIOU MK-2400-001 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00039835, MK-2400-001, EFSTATHIOU

Screening	Repeat 1 time	Cycle length: 42 days	-42 Days	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   MK-2400-001-00_Efstathiou
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ifinatamab Deruxtecan Treatment: Refer to Section 6.6.1 Protocol  Access Hyperlink:  MK-2400-001-00_Efstathiou
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed consent.

Obtain written consent prior to performing any protocol-specific procedures. Rescreening: reconsent only required per local regulations.
See Section 8.1.1.2 regarding informed consent for optional Additional Research.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Enrollment Support Consultation form.

Completion of the Enrollment Support Consultation form is required for the first 3 participants enrolled at each site and can be discontinued after consultation with the Sponsor.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participant ID Card

Provide to participant at the time of informed consent. Update with randomization number at time of randomization (C1D1).
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Informed Consent for Additional Research.  Participation in Additional Research is optional.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Demographics and Medical history

Rescreening: demographics does not need to be repeated at rescreening.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Prostate cancer disease history.

Record locally available biomarker data. See Section 8.8.2 for list of biomarkers requested.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Prior/Concomitant Medication Review.

Report medications started 42 days prior to the first dose and up to 40 days after last dose of study intervention.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	SSRE evaluation
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Treatment eligibility/selection assessment.

The investigator must complete this assessment and document the reason the participant will not receive other approved treatments prior to randomization.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Determine stratification factors.

Complete prior to initiating IRT. See Section 6.3.2 for further information.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Full physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ophthalmologic assessments
An eye examination performed by an ophthalmologist or optometrist includes a visual acuity test, slit lamp examination, tonometry, and fundoscopy. An eye examination will be done at Screening, EOT, and as clinically indicated. Rescreening: If the assessment
was performed during screening, an assessment is not required during rescreening unless clinically indicated.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Tissue for Biomarkers.
Rescreening: If a sample was obtained during screening, an additional sample is not required during rescreening.
Tumor tissue must be obtained after disease progression on the most recent prior therapy.
Participants with bone-only disease must provide an archival soft tumor tissue sample. Bone samples (if bone sample does not contain soft tissue) are not acceptable. See Section 8.1.13. Testing of these specimens for B7-H3 expression will be required by a central laboratory prior to randomization.
			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events

Collect AEs (including IRRs) and SAEs. Additional details are in Section 8.4.1.
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	Echo or MUGA

The same test should be used for the participant throughout the study. If ECHO/MUGA scan is
performed as part of standard of care within 14 days before signed informed consent, results could be considered to assess participant's eligibility.
ECHO or MUGA scan assessments will be performed at Screening and at the EOT Visit.
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	Echo or MUGA

The same test should be used for the participant throughout the study. If ECHO/MUGA scan is performed as part of standard of care within 14 days before signed informed consent, results could be considered to assess participant's eligibility.
ECHO or MUGA scan assessments will be performed at Screening and at the EOT Visit.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be taken while the participant is in a supine/semi recumbent position for 5 minutes or more. ECGs will be taken in triplicate at Screening only.
			Imaging
☑	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Screening CT/MRI chest/abdomen/pelvis and whole-body Tc99m bone scan must be performed within 42 days prior to randomization.
		☑	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
◯	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	whole-body Tc99m bone scan must be performed within 42 days prior to randomization.
		◉	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	whole-body Tc99m bone scan must be performed within 42 days prior to randomization.
			Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	ONLY for participants with a history of brain metastases or who are clinically symptomatic.
Screening: Brain imaging must be performed within 42 days before randomization
				Within -10 days	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs to be collected prior to study treatment administration. Vital signs (temperature, blood pressure, pulse rate, respiratory rate, and SpO2) are measured after 5-minute rest.
			Nursing Orders
  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --	Comments:	Height will be measured at screening only.
			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	If >=10% change in body weight occurs, weight-based therapy should be readjusted.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Screening performed within 10 days before the first study intervention. If performed within 3 days before the first study intervention, assessments do not have to be repeated at C1D1.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Screening performed within 10 days before the first study intervention. If performed within 3 days before the first study intervention, assessments do not have to be repeated at C1D1.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	No testing is required unless mandated by the local health authority. See Sections 8.1.14 and 8.1.15
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	For Arm 1 (I-DXd), urinalysis is only needed at screening and EOT.
For Arm 2, obtain at screening, C1D1, every other cycle (D1 of C3, C5, etc), and EOT.
			Labs
  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	Total testosterone is determined every 4 cycles (eg, C1D1, C5D1, C9D1, etc).
			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --	Comments:	PSA by central laboratory.

Screening: Obtain within 10 days before randomization.
If PSA is collected within 10 days before randomization, an additional PSA is not required at randomization. If the central laboratory result is not available before randomization, the PSA test may also be performed locally to determine eligibility.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Rescreening is an optional, distinct visit from screening, see Section 8.11.2 for details. Participants may be rescreened up to 2 times after initially failing to meet the inclusion/exclusion criteria.
If during the initial Screening the participant screen fails, then the initial Screening period will end and the participant may be rescreened in a new 42-day screening period after consultation between the investigator and Sponsor and written documentation of the decision