Neoplasm, ProstatePhase 1/2ADEBARNCT03322020
Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer
A Phase 1/2 study testing Cyberknife boost 18 Gy and Cyberknife boost 21 Gy in people with Neoplasm, Prostate, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Neoplasm, Prostate
- What is being tested?
- Cyberknife boost 18 Gy and Cyberknife boost 21 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2016to 30 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer
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.
- Conditions
- Neoplasm, Prostate
- Being tested
- Cyberknife boost 18 Gy, Cyberknife boost 21 Gy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberknife boost 18 GyRadiation
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
Cyberknife boost 21 GyRadiation
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx
| Study group | Role | What they receive |
|---|---|---|
| CK 18 Gy | Experimental | Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions Receives: Radiation: Cyberknife boost 18 Gy |
| CK 21 Gy | Experimental | Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions Receives: Radiation: Cyberknife boost 21 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity assessment for 18 Gy and 21 Gy arm
CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)
Measured: 3 months
Secondary outcomes (2)
Biochemical control free survival
PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy
Measured: 3 years
Late toxicity assessment for 18 Gy and 21 Gy arm
Late Effects of Normal Tissues (LENT) scoring system
Measured: average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start21 Mar 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, ProstateStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Seok Kim, Asan Medical Center
- Investigators
- Young Seok Kim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322020
- Sponsor's protocol ID
- S2016-0351-0001
- Acronym
- ADEBAR
- Status last verified
- Jul 2019
- First submitted
- 17 Oct 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33032643Kim 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.
PubMed 29609646
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03322020
- Acronym / sponsor ID
- ADEBAR / S2016-0351-0001
- Conditions
- Neoplasm, Prostate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CK 18 Gy | Experimental | Radiation: Cyberknife boost 18 GyPatients who receive Cyberknife boost dose of 18 Gy in 3 fractions |
| CK 21 Gy | Experimental | Radiation: Cyberknife boost 21 GyPatients who receive Cyberknife boost dose of 21 Gy in 3 fractions |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberknife boost 18 Gypelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx | Radiation | CK 18 Gy |
| Cyberknife boost 21 Gypelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx | Radiation | CK 21 Gy |
Primary outcome
Acute toxicity assessment for 18 Gy and 21 Gy arm
Time frame: 3 months
CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)
2 secondary outcomes
Biochemical control free survival
Time frame: 3 years
Late toxicity assessment for 18 Gy and 21 Gy arm
Time frame: average 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 33032643Kim 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.
- Derived from this study: PubMed 29609646Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Seok Kim, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyberknife boost 18 Gy and Cyberknife boost 21 Gy in people with Neoplasm, Prostate, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity assessment for 18 Gy and 21 Gy arm (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.