Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
NCT ID: NCT07015138
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
390 participants
INTERVENTIONAL
2025-06-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ARM A
Comprehensive Radiotherapy + Standard Systemic Therapy
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)
Arm B
Primary Radiotherapy + Standard Systemic Therapy
NTRT
Standard primary radiotherapy:
* Targets: Prostate primary tumor only
* Concurrent therapy: Same systemic treatment as experimental arm
Interventions
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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)
NTRT
Standard primary radiotherapy:
* Targets: Prostate primary tumor only
* Concurrent therapy: Same systemic treatment as experimental arm
Eligibility Criteria
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Inclusion Criteria
* Histopathologically confirmed acinar adenocarcinoma of the prostate. The presence of a minor component of ductal adenocarcinoma, intraductal carcinoma, and/or neuroendocrine differentiation is permitted.
* PSMA PET performed within 4 weeks prior to the start of study drug therapy or up to 4 weeks after initiation, demonstrating the presence of 1 to 10 metastatic lesions.Metastasis within pelvic lymph nodes (N1 disease) is permitted but not counted towards the total number of metastatic lesions. Metastasis to non-regional lymph nodes is permitted and counted towards the total number.The pelvis is anatomically divided into 4 regions: left hemipelvis (ilium/ischium/pubis), right hemipelvis (ilium/ischium/pubis), sacrum, and coccyx. Multiple lesions within a single anatomical division are aggregated and counted as one metastatic lesion.
* Prior androgen deprivation therapy (ADT) is permitted if the total duration was ≤ 12 months before enrollment. ADT includes luteinizing hormone-releasing hormone (LHRH) agonists or antagonists and novel hormonal agents (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
* Eastern Cooperative Oncology Group (ECOG) score 0-2.
* Hematology: Neutrophil count \>=1.0×10\^9/L; Platelet count \>=75×10\^9/L; Hemoglobin \>=90 g/L.
Exclusion Criteria
* The primary focus has received external radiation therapy, brachytherapy, and radical prostatectomy.
* Received non-endocrine systemic therapies prior to enrollment (e.g., chemotherapy, targeted therapy, radionuclide therapy).
* Metastatic castration-resistant prostate cancer (mCRPC) phase (EAU Guidelines\*).
* Presence of visceral metastases (e.g., liver, lung).
* Previous bilateral orchiectomy.
* 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.
* Definition of mCRPC (EAU Guidelines):
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:
1. PSA progression: A sequence of at least three consecutive rises in PSA, measured ≥1 week apart, resulting in a ≥50% increase from the nadir (lowest) level, with a minimum absolute PSA value \>2 ng/mL.
2. Radiographic progression: The appearance of new lesions, defined as either:
* ≥2 new lesions on bone scan (Tc-99m bone scintigraphy), or
* New measurable soft tissue lesions according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.
3. Unequivocal clinical progression: Clinical progression in the absence of concurrent PSA or radiographic progression should be viewed with suspicion and mandates further investigation to confirm disease progression.
18 Years
85 Years
MALE
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Principal Investigators
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Hong-zhen Li
Role: STUDY_CHAIR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROLONG-3
Identifier Type: -
Identifier Source: org_study_id
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