Actively Recruiting
Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
Led by Peking University First Hospital · Updated on 2025-08-20
390
Participants Needed
3
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 85 years
- Histopathologically confirmed acinar adenocarcinoma of the prostate, including minor ductal, intraductal, or neuroendocrine components
- PSMA PET scan within 4 weeks before or up to 4 weeks after starting therapy showing 1 to 10 metastatic lesions
- Metastases in pelvic lymph nodes allowed but not counted toward total; non-regional lymph node metastases counted
- Prior androgen deprivation therapy (ADT) allowed if duration was 12 months or less before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Blood counts: neutrophils ≥1.0 x10^9/L, platelets ≥75 x10^9/L, hemoglobin ≥90 g/L
You will not qualify if you...
- Small cell carcinoma of the prostate or prostate sarcoma
- Prior external radiation therapy, brachytherapy, or radical prostatectomy to the primary tumor
- Received non-endocrine systemic therapies before enrollment (e.g., chemotherapy, targeted therapy, radionuclide therapy)
- Metastatic castration-resistant prostate cancer phase
- Presence of visceral metastases such as liver or lung
- Previous bilateral orchiectomy
- Severe comorbidities affecting survival or treatment tolerance, including NYHA Class III/IV heart failure or uncontrolled arrhythmias, renal insufficiency with eGFR <30 mL/min/1.73m2, and neuropsychiatric disorders impairing protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Not Yet Recruiting
Research Team
H
Hong-zhen Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here