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Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer

NCT07015138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Hong-zhen Li · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-01-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015138 on ClinicalTrials.gov