Condition: Prostate Cancer · Oligometastatic Prostate Cancer · Sponsor: Peking University First Hospital
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 evid…
This description comes directly from the study's public registry record.
Hong-zhen Li · +8613718895126 · hongzhen.li@pkufh.com
Always discuss trial participation with your own doctor first.
| Peking University First Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Peking University Cancer Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Peking University Third Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07015138