Oligometastases in prostate cancer: Ablative treatment

Table 3 Summary of clinical trials investigating treatment with stereotactic body radiation therapy in oligometastatic prostate cancer

Study	Study type	Type of patient	No. of metastases	Site of metastases	Intervention	Primary endpoint
NCT02680587 Sidney, Kimmel Comprehensive Cancer Center (ORIOLE)[51]	Phase II	HS	≤ 3	Bone or soft tissue	Observation vs SBRT	Time to progression (Time Frame: 6 mo)
NCT02759783 Royal Marsden Hospital (CORE)[53]	Phase II/III	HS/CR	≤ 3	Extracranial	Standard of Care vs SBRT	Progression Free Survival (Time Frame: 60 mo post treatment)
NCT03569241 PEACE V (STORM) Ghent[54]	Phase II	HS	≤ 3	Pelvic LN	MDT (salvage lymph node dissection or SBRT) vs MDT + WPRT. ADT (6 mo in the two arms)	Metastases-free survival (Time Frame: 2 yr)
NCT02685397 PCS IX[55]	Phase II/III	CR	≤ 4	Any location excluding brain and liver metastasis	LHRH agonist + Enzalutamide vs LHRH agonist + Enzalutamide + SBRT	Radiographic Progression-free Survival (Time Frame: 5 yr)
NCT03361735 City of Hope Medical Center[63]	Phase II	HS	≤ 4	Bone. One lung lesion < 2 cm allowed	ADT + SBRT + Radium Ra223 dichloride	Time to treatment failure (Time Frame: Assessed up to 5 yr)
NCT01818986 Southwestern Medical Center Texas[64]	Phase II	CR	Any number of metastatic site are allowed. However, only up to six sites will be selected for SBRT	Any location except brain metastasis	Sipuleucel-T and SBRT	Time to progression (Time Frame: 4 yr)
NCT02816983 Mayo Clinic Rochester[65]	Phase II	CR	≤ 3	Any location	SBRT	PSA-progression free survival (Time Frame: 1 yr) Overall Survival (Time Frame: 2 yr)
NCT02192788 GICOR Castellon[66]	Phase II	HS/CR	≤ 4	Bone or LN	SBRT	No. of patients without disease progression (Time Frame: 5 yr)

ADT: Androgen deprivation therapy; CR: Castration resistant; HS: Hormone-sensitive; LHRH: Luteinizing hormone-releasing hormone; LN: Lymph node; MDT: Metastasis-directed therapy; PSA: Prostate-specific antigen; SBRT: Stereotactic body radiation therapy; WPRT: Whole pelvic radiotherapy.