RecruitingNot ApplicableNCT06325995

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


Sponsor

Changhai Hospital

Enrollment

428 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study tests a shorter, more concentrated course of radiation therapy (called hypofractionated radiotherapy) given after prostate surgery (prostatectomy). This approach delivers higher doses per session over fewer weeks, which may be just as effective as standard longer radiation courses but more convenient. Researchers are studying its safety and how well it works. **You may be eligible if...** - You have had prostate cancer surgery (radical prostatectomy) - Your post-surgery pathology showed high-risk features (e.g., cancer at surgical margins, spread outside the prostate, or PSA levels rising after surgery) - You are in good general health (ECOG score 2 or less) - You are expected to live more than 5 years **You may NOT be eligible if...** - You have significant urinary problems after your prostate surgery - You have had previous pelvic radiation - You have another active cancer - Your cancer has spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONConventional radiation therapy

66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

RADIATIONHypofractionated radiation therapy

57.5-65 Gy in 23-26 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.


Locations(1)

Changhai hospital

Shanghai, Shanghai Municipality, China

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NCT06325995


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