Table 2.

Selected trials assessing the oncological efficacy of metastasis-directed treatment in oligorecurrent/oligometastatic prostate cancer

Study	Identifier	N°	Setting	MDT	Treatment of the primary	Inclusion criteria	Definition of (oligo-)metastasis	Primary endpoint	Secondary endpoints	Status
PEACE V: Phase II trial on Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)	NCT03569241	178	•MDT + 6 months of ADT versus •MDT + 6 months of ADT + WPRT (45 Gy in 25 fractions)	SBRT or SLND	RPx, RT or RPx ± prostate bed adjuvant/salvage RT	•Histologically proven PCa; oligorecurrent •Biochemical relapse after radical LT •Nodal relapse in the pelvis on choline, PSMA, or FACBC PET/CT with a maximum of 3 positive nodal lymph nodes (≤5 nodes) •WHO PS 0-1	•Absence of bone or visceral metastases •Absence of lymph node metastases above the aortic bifurcation	Metastases-free survival	•Clinical/biochemical PFS •Acute/late toxicity •QOL •OS/CSS •CRPC-free survival •Time to hormonal treatment •Quality-adjusted life years •Sensitivity/specificity of PET/CT	Recruiting
PLATON: Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer	NCT03784755	410	•SST + LT to untreated prostate primary (low volume) versus •SST + LT to untreated prostate primary (low volume) + MDT	SBRT and/or surgery to all sites of disease	NR	•Histologically proven PCa; oligometastatic •Stage IV at presentation or relapse after curative-intent therapy •Absence of prior treatment with ADT in the neoadjuvant or adjuvant ≤12 months before randomization •Absence of de novo stage IV disease N1 M0 without prior primary-directed treatment with curative intent •ECOG PS 0-1	•M1 disease with ≤5 metastases •≤3 metastases in any non-bone organ system	FFS	•Radiographic PFS •Metastases-free survival •OS •Adverse events •QOL •Economic aspects	Recruiting
SPARKLE: Randomized phase III trial on Metastasis-directed Therapy for Oligorecurrent Prostate Cancer	NCT05352178	873	•MDT versus •MDT + 1 month of ADT •MDT + 6 months of ADT + enzalutamide	SBRT and/or surgery	NR	•Histologically proven PCa; oligorecurrent •Biochemical recurrence defined (PSA >0.2 ng/ml) after RPx + post-operative RT and PSA of 2 ng/ml above the nadir after high-dose RT •WHO PS 0-2	•≤5 extracranial metastases in any organ •Diagnosed on PSMA-PET/CT/MRI •Nodal (N1) only when accompanied by M1a-c disease (≤5)	Poly-metastatic-free survival	•Metastatic CRPC-free survival •Clinical/biochemical PFS •CSS •OS •Acute/late toxicity •QOL	Recruiting

ADT, androgen deprivation therapy; CRPC, castration-resistant prostate cancer; CSS, cancer-specific survival; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; FACBC, fluorocyclobutanecarboxylic acid; FFS, failure-free survival; LT, local therapy; MDT, metastasis-directed treatment; NR, not reported; OS, overall survival; PCa, prostate cancer; PET, positron emission tomography; PFS, progression-free survival; PS, performance score; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; QOL, quality of life; RPx, radical prostatectomy; RT, radiotherapy; SBRT, stereotactic body radiation therapy; SLND, salvage lymph node dissection; SST, standard systemic therapy; WPRT, whole pelvis radiotherapy.