Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Radical hypofractionated radiotherapy for localized prostate cancer

Official title: Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial

Run by Changhai Hospital · NCT06325774 · Data updated 2026-11-12

This study is testing a new way of giving radiation therapy to see if it can safely treat localized prostate cancer while causing fewer side effects.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment20 (estimated)
SponsorChanghai Hospital
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 1, 2024
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2031
Registry record updatedAugust 26, 2024
Trial IDNCT06325774 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adult males aged 18 and older with pathologically diagnosed localized prostate cancer and an expected survival time of more than five years.

Probably not a fit

Patients who have previously undergone treatments for prostate cancer or have other malignancies may not benefit from this study.

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

What this trial studies

This trial investigates the safety outcomes of hypofractionated radiotherapy in patients with localized prostate cancer. The approach involves delivering higher doses of radiation over a shorter time frame, which may enhance tumor cell destruction while minimizing side effects. Patients will receive a total of 54 Gy in 15 daily fractions of 3.6 Gy, followed by a structured follow-up for five years to monitor various health outcomes. The study aims to assess both the primary toxicities related to gastrointestinal and genitourinary symptoms, as well as secondary endpoints like progression-free survival and overall quality of life.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less burdensome option for patients with localized prostate cancer.

How similar studies have gone: Accumulating evidence suggests that hypofractionated radiotherapy has been safe and feasible for localized prostate cancer, indicating potential success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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 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;
* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
* Patients unable to provide written informed consent or demonstrate poor treatment compliance

Where it's running

  • Changhai hospital
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.