Comparing two types of radiotherapy for localized prostate cancer after surgery

Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial

This study is testing whether a new type of radiotherapy after prostate surgery is safer and more effective than the standard treatment for men with localized prostate cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sex: Male
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06325995 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed localized prostate cancer who have completed radical prostatectomy and meet specific postoperative criteria.

Not a fit: Patients with poor recovery of postoperative urinary control or those who have received prior pelvic and abdominal radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective radiotherapy option for patients with localized prostate cancer.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Changhai hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Huojun Zhang

Conditions Localized Prostate Cancer