Clinical Trials of Prostate-Specific Membrane Antigen Radiopharmaceutical Therapy

Hossein Jadvar; Patrick M. Colletti

doi:10.2967/jnmt.122.264928

Article Figures & Data

Tables

View popup

TABLE 1.

Clinical Trials of PSMA RPT

Trial	Year	Subjects (n)	Location	Description	Diagnostic agent	Therapeutic agent	Clinical phase	Outcome	Comments
LuPSMA (7)	2018	30	Australia	Prospective phase 2, single-center, single-arm trial	⁶⁸Ga, no ¹⁸F-FDG+	¹⁷⁷Lu	mCRPC	PSA50 achieved by 57%	Grade 1 xerostomia in 87% and grade 3–4 thrombocytopenia in 13%
TheraP (8), NCT03392428	2021	35	Australia	Randomized phase 2 trial	⁶⁸Ga, no ¹⁸F-FDG+	¹⁷⁷Lu	mCRPC	¹⁷⁷Lu-PSMA more effective than cabazitaxel	RPT with less grade 3–4 toxicity (33%) than cabazitaxel (53%); RPT with 61% grade 1–2 xerostomia
VISION (9), NCT03511664	2022	831	International	Open-label, 2:1 randomized, phase 3 trial of ¹⁷⁷Lu-PSMA + SOC vs. SOC; previously treated with at least 1 ARPI and taxane	⁶⁸Ga	¹⁷⁷Lu	mCRPC	PFS (median, 8.7 vs. 3.4 mo); OS (median, 15.3 vs. 11.3 mo)	Adverse events of grade ≥ 3 higher with ¹⁷⁷Lu-PSMA than without (52.7% vs. 38.0%)
EnzaP (20), NCT04419402	2020	160	Australia	Open-label, 1:1 randomized, phase 2 trial of ENZ alone or ENZ + ¹⁷⁷Lu-PSMA	⁶⁸Ga	¹⁷⁷Lu	mCRPC	PSA PFS	Ongoing prospective trial
PSMAFore (21), NCT04689828	2022	Estimation: 450	International	Open-label, phase 3, multicenter trial	⁶⁸Ga	¹⁷⁷Lu	mCRPC	rPFS	Ongoing prospective trial
PSMAddition (22), NCT04720157	2022	Estimation: 1,126	International	Open-label, phase 3, 1:1 randomized trial of RPT + SOC vs. SOC	⁶⁸Ga	¹⁷⁷Lu	mCSPC	rPFS	Ongoing prospective trial
UPFrontPSMA (23), NCT04343885	2021	Estimation: 140	Australia	Open-label, multicenter, phase 2, 1:1 randomized trial of RPT + DTX vs. DTX	⁶⁸Ga	¹⁷⁷Lu	mCSPC	Undetectable PSA at 1 y	Ongoing prospective trial
SPLASH (24), NCT04647526	2021	Estimation: 260	International	Open-label, multicenter, phase 3 trial	⁶⁸Ga or ¹⁸F	¹⁷⁷Lu	mCRPC	rPFS	Ongoing prospective trial
ECLIPSE (25), NCT05204927	2022	Estimation: 400	United States	Open-label, multicenter, phase 3 trial	⁶⁸Ga or ¹⁸F	¹⁷⁷Lu	mCRPC	rPFS	Ongoing prospective trial
LuTectomy (26), NCT04430192	2021	20	Australia	Open-label, phase 1/2, nonrandomized trial of dosimetry, efficacy, safety of ¹⁷⁷Lu-PSMA	⁶⁸Ga	¹⁷⁷Lu	High-risk prostate cancer	Absorbed radiation dose of prostate and metastatic lymph nodes	Ongoing prospective trial
PRINCE (27), NCT03658447	2022	37	Australia	Phase 1/2, safety and efficacy trial of RPT and programmed death 1 inhibitor	⁶⁸Ga	¹⁷⁷Lu	mCRPC	PSA50	Ongoing prospective trial
LuPARP (28), NCT03874884	2022	52	Australia	Phase 1 dose-escalation and dose-expansion trial	⁶⁸Ga	¹⁷⁷Lu	mCRPC	Primary outcomes: DLT, MTD, and RP2D	Ongoing prospective trial
TATCIST (29), NCT05219500	2022	Estimation: 100	Texas	²²⁵Ac-PSMA I&T	⁶⁸Ga	²²⁵Ac	mCRPC	PSA50	Ongoing prospective trial

¹⁷⁷Lu-PSMA = ¹⁷⁷Lu-PSMA-617; ARPI = androgen receptor pathway inhibitor; PFS = progression-free survival; ENZ = enzalutamide; DTX = docetaxel; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; RP2D = recommended phase 2 dose.