Prostate adenocarcinoma
Conditions
Interventions
ADT-Only group (Control group):Androgen Deprivation Therapy (ADT)
Radiotherapy group (Experimental group):Androgen Deprivation Therapy (ADT) combined with pelvic radiotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. Pathologically confirmed prostate adenocarcinoma; 3. Have undergone radical prostatectomy and pelvic lymph node dissection, with postoperative pathology indicating positive pelvic lymph nodes (according to AJCC 8th edition, including external iliac, internal iliac, obturator lymph nodes, presacral, periprostatic, and/or perirectal lymph nodes); 4. ECOG score 0-2; 5. Patients who have started GnRH agonist/antagonist therapy after prostatectomy, with less than 1 year of androgen deprivation therapy. 6. No significant dysfunction of major organs: (1) Hemoglobin >= 90 g/L; (2) Platelet count >= 75 x 10^9/L; (3) Total bilirubin <= 3 times the institutional upper limit of normal (ULN); (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 5 times ULN; 7. Effective contraception must be used during the study and for 3 months after the study. 8. The subject has given consent and signed the informed consent form, is willing and able to comply with scheduled visits, study treatments, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Post-radical surgery pelvic MRI or CT shows assessable pelvic recurrent lesions (according to RECIST 1.1 criteria, including tumor bed and lymph nodes). 2. Radiologically confirmed distant metastasis (including M1a, M1b, M1c). 3. Neoadjuvant endocrine therapy for prostate cancer prior to radical surgery exceeding 3 months.* 4. Malignant tumor within 5 years, and its natural course or treatment may interfere with the assessment of the study protocol's safety or efficacy. 5. Before enrollment, the patient has reached castration-resistant status according to the 2025 EAU criteria, i.e., biochemical progression (PSA rising in three consecutive tests, each at least one week apart, resulting in a PSA increase of more than 50% above the lowest level, and PSA > 2 ng/mL) or radiographic progression (new lesions: =2 new bone lesions on bone scan, or at least one soft tissue lesion meeting RECIST criteria). 6. Previous radiotherapy field may overlap with this study, potentially causing damage to normal organs. 7. Presence of severe comorbidities that may affect treatment implementation. 8. Presence of psychiatric disorders preventing understanding and cooperation with treatment and follow-up. 9. The investigator believes there are any other factors making the subject unsuitable for participation in the study. * A half-month window period is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs);5-year biochemical progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from non-protocol hormone therapy;Health-Related Quality of Life (EORTC QLQ-C30 Global Health Status Score);Clinical progression-free survival (cPFS);Locoregional failure-free survival (LRFS);Castration-resistant prostate cancer-free survival (CRPC-FS);Overall Survival (OS);Metastasis-free survival (MFS);Prostate cancer-specific survival (PCSS); | — |
Countries
China
Contacts
Public ContactLiru He
Sun Yat-sen University Cancer Center
Outcome results
None listed