Condition: Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic, Androgen Deprivation Therapy, Lymph Node Positive

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07477626

Sponsor: Sun Yat-sen University

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Age ≥ 18 years.
• Histologically confirmed adenocarcinoma of the prostate.
• Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and/or perirectal nodes).
• ECOG performance status 0-2.
• Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy*.
• Adequate major organ function, defined as: Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN
• Use of effective contraception during the study and for 3 months after.
• Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.
• Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.

Exclusion Criteria:

• Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).
• Radiographically confirmed distant metastasis (M1a, M1b, or M1c).
• Neoadjuvant hormonal therapy > 3 months before prostatectomy.
• Malignancy within 5 years that may interfere with study safety or efficacy assessments.
• Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
• Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
• Serious comorbidities affecting study treatment.
• Psychiatric disorders preventing understanding or compliance.
• Any condition that, in the investigator's judgment, makes participation unsuitable.

View trial on ClinicalTrials.gov