Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer
NCT ID: NCT03322020
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2016-03-21
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CK 18 Gy
Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions
Cyberknife boost 18 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
CK 21 Gy
Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions
Cyberknife boost 21 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx
Interventions
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Cyberknife boost 18 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
Cyberknife boost 21 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of pelvic LN metastasis
* History of androgen deprivation therapy within 6 months after enrollment
* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)
* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer
20 Years
MALE
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Young Seok Kim
Associate professor
Principal Investigators
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Young Seok Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Kim YJ, Ahn H, Kim CS, Kim YS. Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR). Radiat Oncol. 2020 Oct 8;15(1):234. doi: 10.1186/s13014-020-01665-6.
Kim YJ, Ahn H, Kim CS, Lee JL, Kim YS. Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial. Trials. 2018 Apr 2;19(1):212. doi: 10.1186/s13063-018-2574-y.
Other Identifiers
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S2016-0351-0001
Identifier Type: -
Identifier Source: org_study_id
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