Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial


Condition: Localized Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06325774

Sponsor: Changhai Hospital

Eligibility:

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

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

View trial on ClinicalTrials.gov