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

Neoplasm, Prostate Clinical Trial

— ADEBAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322020
• Other study ID #: S2016-0351-0001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 21, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm, Prostate
• Prostatic Neoplasms

Intervention

Radiation:
• Cyberknife boost 18 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
• Cyberknife boost 21 Gy
pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biochemical control free survival	PSA nadir + 2.0ng/ml or Start of salvage hormonal therapy	3 years
Secondary	Late toxicity assessment for 18 Gy and 21 Gy arm	Late Effects of Normal Tissues (LENT) scoring system	average 6 months