Table 2.

Survival and quality of life outcomes in selected randomized phase 2 and 3 studies of ¹⁷⁷Lu-PSMA-617 in progressive PSMA-positive mCRPC.

	TheraP [23]		VISION [24,33]		PSMAfore [27]
Study arms	LuPSMA	Cabazitaxel	LuPSMA	SOC	LuPSMA	ARPI Change
Patients, n	99	101	551	280	234	234
Median imaging-based PFS, months	NR	NR	8.7	3.4	12.0	5.6
HR (95% CI)   p value	0.63 (10.46–0.86) 0.0028		0.40 (0.29–0.57) <0.001		0.41 (0.33–0.54) <0.0001
Median OS, months	NR	NR	15.3	11.3	19.2	19.7
HR (95% CI)   p value	NR		0.62 (0.52–0.75) <0.001		1.16 (0.83–1.64) NR
Median time to HRQOL worsening, months 1	NR	NR	14.3	2.9	7.5	4.3
HR (95% CI)   p value	NR		0.45 (0.33–0.60) <0.001		0.59 (0.47–0.72) NR
Median time to pain worsening, months 2	NR	NR	1.0	0.5	5.0	3.7
HR (95% CI)   p value	NR		0.65 (0.54–0.78) <0.001		0.69 (0.56–0.85) NR

¹ As measured by FACT-P score; ² As measured on BPI-SF scale. ¹⁷⁷Lu, lutetium-177; LuPSMA, ¹⁷⁷Lu-PSMA-617; ARPI, androgen receptor pathway inhibitor; BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; FACT-P, Functional Assessment of Cancer Therapy-Prostate; HR, hazard ratio; HRQOL, health-related quality of life; mCRPC; metastatic castration-resistant prostate cancer; NR, not reported; OS, overall survival; PFS, progression-free survival; PSMA, prostate-specific membrane antigen; SOC, standard of care.