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Completed

NCT Number: NCT03322020

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

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Key information

Conditions

Neoplasm, Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyberknife boost 18 Gy

Radiation

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

Cyberknife boost 21 Gy

Radiation

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Biochemical control free survival

    Time frame: 3 years

    PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy

  2. Late toxicity assessment for 18 Gy and 21 Gy arm

    Time frame: average 6 months

    Late Effects of Normal Tissues (LENT) scoring system

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: ADEBAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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