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NCT06325774Recruiting

Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm 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 study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
16 Mar 2024
Start date
1 Sept 2024
Primary completion date
1 Sept 2026
Lead sponsor
Changhai Hospital
NCT number
NCT06325774

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Sept 2024 to the primary completion date, 1 Sept 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

  • 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 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;

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

  • Patients unable to provide written informed consent or demonstrate poor treatment compliance

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · 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.