Overall Survival (OS)
Time frame · From start of systemic therapy to death from any cause, up to the end of follow-up (approximately 24-30 months).
Time from treatment initiation to death from any cause. Participants alive at last follow-up will be censored.
Biochemical Progression-free Survival (bPFS)
Time frame · From start of systemic therapy to biochemical progression or death, up to ~24 months.
Biochemical progression is defined according to ASTRO/AUA joint guideline: a PSA increase of ≥2 ng/mL above the nadir, confirmed by a second consecutive measurement.
PSA Response Rate at 3 and 6 Months
Time frame · 3 months and 6 months after treatment
Proportion of patients with PSA decline ≥50% from baseline at 3 months and 6 months after treatment initiation
Conversion Success Rate
Time frame · At 6 months (and 12 months for supplementary randomization, if applicable)
Proportion of patients who achieve "conversion success" after 6 months of systemic therapy, defined as PSMA PET/CT showing no metabolically active lesions (all metastases with SUVmax below liver background or blood pool) and fulfilling randomization criteria.
Safety Endpoints
Time frame · From first dose to 30 days after last dose or last study visit
Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI-CTCAE version 5.0, including treatment-emergent AEs, AEs leading to discontinuation, and treatment-related deaths.
Change from Baseline in EORTC QLQ-C30 Score
Time frame · From baseline to 3, 6, 12, and 24 months after randomization.
Changes from baseline in health-related quality of life measured by EORTC QLQ-C30 (e.g., Global Health Status/QoL and functional scales).
Change from Baseline in SF-36 Score
Time frame · From baseline to 3, 6, 12, and 24 months after randomization.
Changes from baseline in health-related quality of life measured by SF-36 (e.g., PCS and MCS).
Change from Baseline in FACT-G Total Score
Time frame · From baseline to 3, 6, 12, and 24 months after randomization.
Changes from baseline in health-related quality of life measured by FACT-G total score.