Radical hypofractionated radiotherapy for localized prostate cancer

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06325774 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility 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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Huojun Zhang

Conditions Localized Prostate Cancer