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NCT03322020: ADEBAR

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

Completed Phase 1, PHASE2 Last updated 5 July 2019
What this trial tests

Phase 1, PHASE2 trial testing Cyberknife boost 18 Gy in Neoplasm, Prostate in 30 participants. Completed in 30 June 2019.

Timeline
21 March 2016
Primary endpoint
30 June 2018
30 June 2019

Quick facts

Lead sponsorAsan Medical Center
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment30
Start date21 March 2016
Primary completion30 June 2018
Estimated completion30 June 2019
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Asan Medical Center

Who can join

20 and older, male only, with Neoplasm, Prostate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR).
    Kim YJ, Ahn H, Kim CS, Kim YS. · · 2020 · cited 4× · PMID 33032643 · DOI 10.1186/s13014-020-01665-6
  2. 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.
    Kim YJ, Ahn H, Kim CS, Lee JL, et al · · 2018 · cited 4× · PMID 29609646 · DOI 10.1186/s13063-018-2574-y

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