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NCT06325995Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
428 (estimated)
First submitted
2 Mar 2024
Start date
1 Feb 2024
Primary completion date
1 Feb 2026
Lead sponsor
Changhai Hospital
NCT number
NCT06325995

What you commit to

  • Study type: Interventional
  • Planned participants: 428
  • From 1 Feb 2024 to the primary completion date, 1 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 contraindications related to radiotherapy;

Other illness

  • 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;

Other

  • poor recovery of postoperative urinary control;
  • 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.

Who the study is looking for

  • 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;

Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changhai Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.