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

Primary Purpose

Neoplasm, Prostate

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyberknife boost 18 Gy
Cyberknife boost 21 Gy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm, Prostate

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CK 18 Gy

CK 21 Gy

Arm Description

Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions

Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biochemical control free survival
PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy
Late toxicity assessment for 18 Gy and 21 Gy arm
Late Effects of Normal Tissues (LENT) scoring system

Full Information

First Posted
October 17, 2017
Last Updated
July 2, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03322020
Brief Title
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer
Acronym
ADEBAR
Official Title
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CK 18 Gy
Arm Type
Experimental
Arm Description
Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions
Arm Title
CK 21 Gy
Arm Type
Experimental
Arm Description
Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions
Intervention Type
Radiation
Intervention Name(s)
Cyberknife boost 18 Gy
Intervention Description
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
Intervention Type
Radiation
Intervention Name(s)
Cyberknife boost 21 Gy
Intervention Description
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx
Primary Outcome Measure Information:
Title
Acute toxicity assessment for 18 Gy and 21 Gy arm
Description
CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Biochemical control free survival
Description
PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy
Time Frame
3 years
Title
Late toxicity assessment for 18 Gy and 21 Gy arm
Description
Late Effects of Normal Tissues (LENT) scoring system
Time Frame
average 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33032643
Citation
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.
Results Reference
derived
PubMed Identifier
29609646
Citation
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.
Results Reference
derived

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

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