Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer

The present study will be conducted as a prospective, open-label, two arms clinical trial.

Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer, will be randomized in a 1:1 ratio between arm A (COPORT) and arm B (HYPORT).

The patients in arm A will receive COPORT(66-74 Gy in 33-37 daily fractions of 2 Gy ). The patients in arm B will receive HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.

The primary endpoints of the study are toxicities parameters.The secondary endpoints include ,progression-free survival (PFS),medical economics,quality of life (QoL), overall survival (OS)and prostate cancer-specific survival period. The progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival.

Inclusion criteria

• European Cooperative Oncology Group score(ECOG):≤ 2;
• Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer;
• Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+), or N1; or serum PSA≥0.1 ng/ml 6 weeks after surgery; or serum PSA <0.1 ng/ml 6 weeks after surgery, subsequent follow-up process revealed two consecutive sustained PSA increases (≥0.1 ng / ml) and no clinical imaging (Whole Body Scan (ECT), magnetic resonance imaging (MRI),68Ga PSMA PET / CT, etc.) signs of metastasis;
• Expected survival time >5 years;
• Patients who voluntarily accept the experimental study protocol after informing the existing treatment options;

Exclusion criteria

• poor recovery of postoperative urinary control;
• a previous history of pelvic and abdominal radiotherapy;
• Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
• Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;
• Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;
• Patients with contraindications related to radiotherapy;
• Written informed consent could not be provided, and treatment compliance was poor.Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.