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

Phase 1

Completed

• Conditions: Neoplasm, Prostate
• Interventions: Radiation: Cyberknife boost 21 Gy; Radiation: Cyberknife boost 18 Gy

• Registration Number: NCT03322020
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-26
• Primary Completion: 2018-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CK 21 Gy	Cyberknife boost 21 Gy	Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions
CK 18 Gy	Cyberknife boost 18 Gy	Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions

Primary Outcome Measures

Name	Time	Method
Acute toxicity assessment for 18 Gy and 21 Gy arm	3 months	CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of