Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer (ADEBAR)

Asan Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Neoplasm, Prostate

Treatments

Radiation: Cyberknife boost 18 Gy

Radiation: Cyberknife boost 21 Gy

Study type

Interventional

Funder types

Other

Identifiers

NCT03322020

S2016-0351-0001

Details and patient eligibility

About

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 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.

Enrollment

30 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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