The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.
It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.
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;
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;
Parallel
Conventional radiation therapy
Radiation66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
Hypofractionated radiation therapy
Radiation57.5-65 Gy in 23-26 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0
5-year progression-free survival (PFS)
To assess progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival.
quality of life (QoL)
Expanded Prostate Cancer Index (EPIC-26)：The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL.
medical expenses
The medical expenses during the time of interventions.The medical expenses include the payments of doctor and hospital visits, co-pays, radiotherapy and so on.
Overall survival (OS)
To assess the overall survival (OS)
Click on the lead sponsor to view all of their trials.
