NCT03322020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

October 17, 2017

Last Update Submit

July 2, 2019

Conditions

Neoplasm, Prostate

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity assessment for 18 Gy and 21 Gy arm

    CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)

    3 months

Secondary Outcomes (2)

  • Biochemical control free survival

    3 years

  • Late toxicity assessment for 18 Gy and 21 Gy arm

    average 6 months

Study Arms (2)

CK 18 Gy

EXPERIMENTAL

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

Radiation: Cyberknife boost 18 Gy

CK 21 Gy

EXPERIMENTAL

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

Radiation: Cyberknife boost 21 Gy

Interventions

Cyberknife boost 18 GyRADIATION

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

CK 18 Gy
Cyberknife boost 21 GyRADIATION

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

CK 21 Gy

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 33032643DERIVED

  • 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.

    PMID: 29609646DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Young Seok Kim, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 26, 2017

Study Start

March 21, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)