NCT03920033 Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
| NCT ID | NCT03920033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2022-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2019-05-01 with a primary completion date of 2022-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Pathologically confirmed intermediate- or high-risk prostate cancer * Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL) * ECOG performance status 0-1 * Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl * Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL * Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value Exclusion Criteria: * Clinically gross recurrent tumor * Presence of distant metastasis * Presence of pelvic LN metastasis * History of pelvic irradiation * History of cryotherapy or brachytherapy for prostate cancer * Double primary cancer other than skin/thyroid cancer * Combined serious morbidity
Contact & Investigator
Young Seok Kim, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT03920033 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03920033 currently recruiting?
Yes, NCT03920033 is actively recruiting participants. Contact the research team at ysk@amc.seoul.kr for enrollment information.
Where is the NCT03920033 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT03920033 clinical trial?
NCT03920033 is sponsored by Asan Medical Center. The principal investigator is Young Seok Kim, M.D., Ph.D. at Asan Medical Center. The trial plans to enroll 288 participants.
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