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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK 18 Gy | Experimental | Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions |
|
| CK 21 Gy | Experimental | Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyberknife boost 18 Gy | Radiation | pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Seok Kim, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032643 | Derived | 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. | |
| 29609646 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Cyberknife boost 21 Gy | Radiation | pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx |
|
| average 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |