NCT07015138

Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer

A Multicenter, Randomized Controlled Clinical Trial Comparing Comprehensive Radiotherapy Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized controlled phase III clinical trial (PROLONG-3) designed to evaluate the survival benefit of comprehensive radiotherapy combined with primary tumor radiotherapy versus primary tumor radiotherapy alone in patients with newly diagnosed oligometastatic prostate cancer. The trial enrolled 390 patients with ≤10 metastatic lesions confirmed by PSMA PET imaging, who were randomized in a 2:1 ratio to either the intervention group (comprehensive radiotherapy + standard systemic therapy) or control group (primary radiotherapy + standard systemic therapy). Stratification factors included Gleason score (GS ≤8 vs. GS 9-10) and number of metastases (1-3 vs. 4-10). The primary endpoint was 3-year progression-free survival (PFS), with secondary endpoints encompassing overall survival (OS), intermittent treatment rate, adverse events (CTCAE v5.0), and quality of life (EORTC QLQ questionnaires). To minimize bias, stratified block randomization and blinded endpoint adjudication were implemented, with treatment effects analyzed using Kaplan-Meier survival curves and Cox proportional hazards models. The study's innovation lies in its definitive evaluation of the added value of comprehensive radiotherapy, combined with exploratory biomarker analyses (including genomic testing) to identify predictive markers of therapeutic response. Should the results demonstrate significant PFS improvement with comprehensive radiotherapy, this would provide high-level evidence to guide clinical practice, potentially influencing treatment guideline updates while optimizing patient quality of life and reducing healthcare burdens.

Conditions

• Prostate Cancer
• Oligometastatic Prostate Cancer

Interventions

Type	Name	Description
RADIATION	TRT	Comprehensive metastasis-directed radiotherapy: * Targets: Primary prostate tumor + all metastatic lesions (≤10 sites confirmed by PSMA PET) * Concurrent therapy: Standard systemic treatment (ADT + novel hormonal agents)
RADIATION	NTRT	Standard primary radiotherapy: * Targets: Prostate primary tumor only * Concurrent therapy: Same systemic treatment as experimental arm

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-01-01
• Completion: 2027-12-31
• First posted: 2025-06-11
• Last updated: 2025-08-20

Locations

3 sites across 1 country: China