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

Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03322020

Acronym

ADEBAR

Enrollment

Registered

2017-10-26

Start date

2016-03-21

Completion date

2019-06-30

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm, Prostate

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 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.

Interventions

RADIATIONCyberknife boost 18 Gy

pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx

RADIATIONCyberknife boost 21 Gy

pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Acute toxicity assessment for 18 Gy and 21 Gy arm	3 months	CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)

Secondary

Measure	Time frame	Description
Biochemical control free survival	3 years	PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy
Late toxicity assessment for 18 Gy and 21 Gy arm	average 6 months	Late Effects of Normal Tissues (LENT) scoring system

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026