Table 2.

Prospective randomized trials evaluating patient outcomes after restaging PET/CT in prostate cancer patients with biochemical recurrence after radical prostatectomy.

Trial	N	Study design	Primary endpoint	Results
Jani et al. (53) EMPIRE I - NCT01666808	165	Phase II/III randomized: 18F-Fluciclovine guided-treatment vs SOC	3-yr event-free survival	- 3-yr event-free survival: 63% SOC vs 75.5% 18F-Fluciclovine PET/CT - 35% treatment change with 18F-Fluciclovine PET/CT
EMPIRE II - NCT03762759	140, recruiting	Phase II randomized: 18F-Fluciclovine vs 68Ga-PSMA	Disease-free survival	- Ongoing trial
INDICATE - NCT04423211	804, recruiting	Phase III randomized, 4 arms: Baseline 18F-Fluciclovine	PFS	- Ongoing trial
		- No extrapelvic uptake:   ○ SOC salvage therapy (LHRH agonists + SRT)   ○ SOC salvage therapy (LHRH agonists + SRT) + Apalutamide
		- Extrapelvic uptake:   ○ SOC salvage therapy (LHRH agonists + SRT) + Apalutamide   ○ SOC salvage therapy (LHRH agonists + SRT) + Apalutamide +MDT
Calais et al. (91) PSMA SRT - NCT03582774	193	Phase III randomized: 68Ga-PSMA guided-treatment vs SOC	5-yr bRFS	Change in SRT plan: 28% SOC vs 57% PSMA PET/CT (ASCO 2020 preliminary results) primary endpoint analysis ongoing
NCT03525288	129	Phase II randomized: 18F-DCFPyL PSMA guided- treatment vs SOC	5-yr FFS	- Primary endpoint analysis ongoing
NCT04794777	450, recruiting	Phase III randomized: PSMA (either 68Ga or 18F-1007) guided-treatment vs SOC	PFS	- Ongoing trial
PATRON - NCT04557501 (definitive and salvage setting)	776, recruiting	Phase III randomized: 18F-DCFPyL PSMA guided- treatment vs SOC	5-yr FFS	- Ongoing trial

PSMA, prostate specific membrane antigen; SOC, standard of care; SRT, salvage radiotherapy; bRFS, biochemical relapse free-survival; RP, radical prostatectomy; MDT, Metastasis Directed Therapy; PFS, Progression Free Survival; LHRH, Luteinizing Hormone Releasing Hormone; FFS, Failure-Free Survival.