Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

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

The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 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 the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).

Inclusion criteria

• Age: ≥18 years old;
• European Cooperative Oncology Group score(ECOG):≤ 2;
• Patients with pathologically diagnosed prostate cancer;
• Clinical stage was cTanyN0M0 any Gleason / ISUP group;
• Expected survival time >5 years;
• The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;
• Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;

Exclusion criteria

• Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
• a previous history of pelvic and abdominal radiotherapy;
• Prior hormonal therapy (castration or antiandrogen);
• 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;
• Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
• Patients unable to provide written informed consent or demonstrate poor treatment compliance