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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Conventional radiation therapy
  • Hypofractionated radiation therapy

Treatment groups

428 Participants
are divided into 2 treatment groups

Sponsors and collaborators