TABLE 4. Example Clinical Trial Design Opportunities for Qualifying Novel Imaging Techniques and Probes in Prostate Cancer.

Imaging Probe or Technology	Clinical Setting	End Point/Comparator	Value Proposition
18F-NaF	Bone metastatic disease	Correlation with treatment response and/or survival, 99mTc-MDP scan	Simpler preparation, more sensitive
MRI (T2-weighted, DCE-MRI, DWI, MRS)	All localized or locally recurrent disease	Repeat biopsy and/or PSA outcomes, disease control outcomes, pathological outcomes	Identification of indolent vs aggressive lesions, active surveillance more acceptable to patients
	Localized disease—androgen deprivation therapy before RP or RT	Ktrans response to therapy, histopathology, conventional MRI, TRUS	Prediction of antiangiogenic therapy performance in other stages and other cancer types
DWI, FDG PET, FDHT, FLT, or other tracers	Bone and lymph node metastatic disease	Correlation with treatment response and/or survival; 99mTc-MDP scanning	Assess relative performance of probes to cytotoxic vs androgen targeting agents, evaluate standards for lesion enumeration, SUV quantitation, etc.

Note—¹⁸F-NAF = ¹⁸F sodium fluoride, MDP = methylene diphosphonate, MRS = MR spectroscopy, DWI = diffusion-weighted MRI, DCE-MRI = dynamic contrast-enhanced MRI, RP = radical prostatectomy, RT = radiation therapy, PSA = prostate-specific antigen, K^trans = volume transfer constant, TRUS = transrectal ultrasound, FDG PET = ¹⁸fluoro-2-deoxyglucose PET, FLT = ¹⁸F-3′-fluoro-3′-deoxy-L-thymidine, FDHT = ¹⁸F-fluorodihydrotestosterone, SUV = standardized uptake value.