Prostate cancer
Conditions
Interventions
Control Arm:Primary Prostate Radiotherapy
Intervention Arm:Radiation therapy to the prostate region + all metastatic lesions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Male patients aged 18-85 years. 2.Pathologically confirmed acinar adenocarcinoma.Presence of admixed ductal adenocarcinoma, intraductal carcinoma, or neuroendocrine differentiation is permitted. 3.PSMA PET performed within 4 weeks before or after initiation of drug therapy, demonstrating 1-10 metastatic lesions.Pelvic lymph node metastases (N1) are allowed but are not counted towards the total number of metastatic lesions.Non-regional lymph node metastases are permitted.The pelvis is anatomically divided into 4 parts: left hip bone, right hip bone, sacrum, and coccyx. Multiple lesions within a single part are counted as one metastatic lesion. 4.Prior endocrine therapy =12 months before enrollment is permitted.Endocrine therapies include Luteinizing Hormone-Releasing Hormone (LHRH) agonists/antagonists, novel endocrine therapies, etc. 5.ECOG Performance Status 0-2. 6.Laboratory values meeting the following criteria. Hematology: (1)Absolute neutrophil count (ANC) >= 1.0 × 10?/L (>= 1000/µL) (2)Platelet count >= 75 × 10?/L (>= 75,000/µL) (3)Hemoglobin (Hb) >= 90 g/L (>= 9.0 g/dL)
Exclusion criteria
Exclusion criteria: 1.Pathology consistent with prostate small cell carcinoma or prostate sarcoma 2.Primary tumor previously treated with external beam radiotherapy (EBRT), brachytherapy, or radical prostatectomy (RP). 3.Received any systemic therapy other than endocrine therapy prior to enrollment, such as chemotherapy, targeted therapy, or radionuclide therapy. 4.Metastatic castration-resistant prostate cancer (mCRPC) stage per EAU guidelines*. 5.Presence of visceral metastases. 6.History of bilateral orchiectomy. 7.Presence of significant comorbidities (e.g., severe cardiovascular disease, renal insufficiency, psychiatric disorders) that may impact survival prognosis or preclude safe participation in this study's treatment regimen. *Supplementary Definition of mCRPC per EAU Guidelines: Serum testosterone level 2 ng/mL. (2) Radiographic Progression: * New lesions: =2 new lesions on bone scan, OR * New soft tissue lesions meeting RECIST (Response Evaluation Criteria In Solid Tumors) criteria. (3) Unequivocal Clinical Progression: Symptomatic progression alone requires careful scrutiny and warrants further investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to PSA progression;Overall survival (OS);3-year treatment discontinuation rate;Quality of life (QoL);Adverse events (AEs) / Toxicity;Time to initiation of subsequent anti-tumor therapy;Complete PSA response rate; 3-year treatment discontinuation rate (in patients with normalized testosterone);Radiographic progression-free survival (rPFS); | — |
Countries
China
Contacts
Public ContactLi Hongzhen
Peking University First Hospital
Outcome results
None listed