An interventional study of TRT and NTRT in Prostate Cancer and Oligometastatic Prostate Cancer, sponsored by Peking University First Hospital. Recruiting at 3 sites in China. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 390 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Comorbidities: Severe comorbidities affecting survival or treatment tolerance, including: Cardiovascular diseases (NYHA Class III/IV heart failure, uncontrolled arrhythmias); Renal insufficiency (eGFR \<30 mL/min/1.73m\^2); Neuropsychiatric disorders impairing protocol compliance.
Metastatic castration-resistant prostate cancer (mCRPC) is defined as disease progression despite serum testosterone levels below 50 ng/dL (or 1.7 nmol/L), concurrently with one or more of the following:
Radiographic progression: The appearance of new lesions, defined as either:
Comprehensive Radiotherapy + Standard Systemic Therapy
Radiation: TRT
Primary Radiotherapy + Standard Systemic Therapy
Radiation: NTRT
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)
Standard primary radiotherapy: * Targets: Prostate primary tumor only * Concurrent therapy: Same systemic treatment as experimental arm
3-year progression-free survival (PFS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Time to PSA progression
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Overall survival (OS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Quality of life (QoL)
Measure Tools: EORTC QLQ-C30 (Version 3.0): Global health status (Items 29-30), functional scales (physical, role, emotional, cognitive, social), and symptom scales (fatigue, pain, nausea, etc.). Scale Range: 0-100 for all domains. Interpretation: Higher scores = better functioning (global/functional scales) or worse symptoms (symptom scales). QLQ-PR25: Prostate cancer-specific module (symptoms, treatment side effects, sexual function). Scale Range: 0-100 for all subscales Interpretation: Higher scores = worse symptoms (urinary, bowel, treatment-related). Sexual Activity Subscale: Higher scores = more sexual activity (better functioning). Sexual Functioning Subscale: Higher scores = worse sexual function (e.g., erectile dysfunction).
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Adverse events (AEs) / Toxicity
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Time to initiation of subsequent anti-tumor therapy
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate (in patients with normalized testosterone)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Radiographic progression-free survival (rPFS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Complete PSA response rate
Definition: According to Prostate Cancer Working Group 3 (PCWG3) criteria, the following conditions must be met: PSA level decreases to undetectable levels (≤0.2 ng/mL). Confirmed by two consecutive measurements (≥4 weeks apart) with no clinical/radiographic progression (per RECIST 1.1). Measurement Tools: PSA Assay Method: Electrochemiluminescence immunoassay (ECLIA) or isotope dilution liquid chromatography-mass spectrometry (ID-LC/MS), with a lower limit of quantification (LLoQ) of 0.02 ng/mL. Radiographic Confirmation: Exclude disease progression (bone scan/CT/MRI per RECIST 1.1). Statistical Analysis: Proportion (%) of patients meeting the above criteria, with two-sided 95% confidence intervals.
Time frame: 6 months after radiotherapy
Plan to share: No
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Peking University First Hospital