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

Study Overview
=================
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.

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

Conditions
-----------------
Neoplasm, Prostate

Intervention / Treatment
-----------------
* Radiation: Cyberknife boost 18 Gy
* Radiation: Cyberknife boost 21 Gy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CK 18 Gy<br>Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions | Radiation: Cyberknife boost 18 Gy<br>* pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx<br>|
| Experimental: CK 21 Gy<br>Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions | Radiation: Cyberknife boost 21 Gy<br>* pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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