Comparing two types of radiotherapy for localized prostate cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the safety outcomes of hypofractionated post-prostatectomy radiotherapy (HYPORT) with conventionally fractionated post-prostatectomy radiotherapy (COPORT) in patients who have undergone radical resection for localized prostate cancer. Patients will be randomly assigned to receive either COPORT or HYPORT, with follow-up assessments conducted for up to five years to evaluate toxicities, progression-free survival, quality of life, and overall survival. The study seeks to determine the optimal dosing regimen for HYPORT and its effectiveness compared to COPORT.

Why it matters

Who can join: the full rules

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.

Where it's running

• Changhai hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Huojun Zhang
• Email: huojunzh@163.com
• Phone: 021-31162222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Oxybutynin ER to help early urinary continence after robotic prostatectomy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.