Table 2.

Ongoing/future trials evaluating radiotherapy/MDT in (oligo)metastatic prostate cancer.

Study	Disease Type	Metastatic Burden	Study Type	Randomization (if applicable)	Primary Outcome
STAMPEDE Arm M	De novo OMD	≤5 lesions	Phase III RCT	SOC (+ prostate RT/surgery) vs. SOC (+ prostate RT/surgery) + MDT	OS
NCT03298087	De novo OMD	≤5 lesions	Single-arm Phase II	Prostatectomy + MDT + adjuvant RT with 6 months of ADT/apalutamide/abiraterone	PSA <0.05ng/mL 6 months after recovery of testosterone
PLATON	De novo OMD and ORD	≤5 lesions	Phase III RCT	SOC* vs. SOC* + MDT	FFS at 6 years
NRG-GU011	ORD	≤5 lesions	Phase II RCT	MDT + placebo vs. MDT + relugolix	rPFS by conventional imaging
DART	ORD	≤5 lesions	Phase II RCT	MDT vs. MDT + darolutamide	MFS at 2 years by PET
RADIOSA	ORD	≤3 lesions	Phase II RCT	MDT vs. MDT + LHRH agonist/antagonist	PFS
ECOG-ACRIN 8191	Biochemical recurrence	No limit**	Phase III RCT	Salvage RT + ADT/apalutamide vs. Salvage RT + ADT/apalutamide + MDT	PFS, QOL
FORCE	OPD	≤5 lesions	Phase II RCT	SOC vs. SOC + SBRT to all sites of disease	Mean response duration
PEACE-1	De novo metastatic disease	No limit	Phase III RCT	SOC (ADT +/- docetaxol) vs. SOC + abiraterone vs. SOC + prostate RT vs. SOC + abiraterone + prostate RT	OS, rPFS

*SOC includes ablative therapy (surgery or SBRT) to prostate for patients with untreated prostate primary and low volume metastatic disease. **Conventional imaging negative, no limit on 18F-fluciclovine PET positive lesions.

OMD, oligometastatic disease; RCT, randomized controlled trial; SOC, standard of care; MDT, metastasis-directed therapy; OS, overall survival; ADT, androgen deprivation therapy; PSA, prostate-specific antigen; ORD, oligorecurrent disease; SBRT, stereotactic body radiotherapy; FFS, failure-free survival; rPFS, radiographic progression-free survival; MFS, metastasis-free survival; LHRH, luteinizing hormone-releasing hormone; PFS, progression-free survival; QOL, quality of life; OPD, oligoprogressive disease; RT, radiotherapy.