Status:
COMPLETED
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Neoplasm, Prostate
Eligibility:
MALE
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 f...
Eligibility Criteria
Inclusion
- Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment
- 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
- Presence of distant metastasis
- 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
Key Trial Info
Start Date :
March 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03322020
Start Date
March 21 2016
End Date
June 30 2019
Last Update
July 5 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505