TABLE 6

Clinical Trial Design with ¹¹C-Methionine Tracers in Metastatic Prostate Cancer

Author and year	n	Tracer	Clinical state	Study	Purpose and endpoint	Statistical method	Conclusion
Nunez et al. (64), 2002	12	¹¹C-methionine and ¹⁸F-FDG	Metastatic castration-sensitive and -resistant	Prospective	Purpose: disease detection (metastatic)	Lesion-based sensitivity	¹⁸F-FDG sensitivity, 48% (167/348)
		¹¹C-methionine and ¹⁸F-FDG	Metastatic castration-sensitive and -resistant		Endpoint: lesions assessed with CIM	Paired t-test	¹¹C-methionine sensitivity, 72.1% (251/348)
Tóth et al. (65), 2005	20	¹¹C-methionine	Rising PSA (with repeated negative biopsies)	Prospective	Purpose: disease detection (local) for prostate biopsy.	None	Overall detection rate, 46.7% (7/15)
			Rising PSA (with repeated negative biopsies)		Endpoints:
					Lesions assessed with CIM
					Follow-up CIM