RecruitingNot ApplicableNCT03920033

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study


Sponsor

Asan Medical Center

Enrollment

288 participants

Start Date

May 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence. It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.


Eligibility

Sex: MALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two radiation approaches after prostate removal — a shorter, more intense course versus the standard longer course — for men whose PSA (a prostate cancer blood marker) has started rising after surgery, suggesting the cancer may be coming back. **You may be eligible if...** - You had confirmed intermediate- or high-risk prostate cancer and underwent prostate removal surgery - Your PSA has been rising and is between 0.2 and 1.0 ng/mL (biochemical recurrence) - You are in good general health (ECOG 0-1) with adequate blood, kidney, and liver function **You may NOT be eligible if...** - You have a visible or palpable recurrent tumor or distant cancer spread - Your blood or organ function tests are below the required thresholds 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

RADIATIONSalvage radiation therapy

Salvage radiation therapy for biochemical recurrence


Locations(2)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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NCT03920033


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