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This is a phase 2 randomized study for High risk localized prostate cancer (T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8) without evidence of distant and nodal metastasis.
Patient will be randomized to:Arm 1
or Arm 2
SBRT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional IMRT | Experimental |
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| SBRT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional IMRT | Radiation | RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes). 38 fractions of daily treatment, Monday to Friday. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare acute toxicities between SBRT and conventional IMRT | Toxicities will be assessed by AE CTC version 4 between 2 treatment arms | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT | Questionnaire EPIC will be used at pre-treatment, during treatment and at 3, 6, 9, 12, 18 and 24 months post treatment | 4 years |
| To compare the biochemical-failure free survival at 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong | Hong Kong |
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| SBRT | Drug | RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes) 5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy. |
|
| 5 years |
| To compare the progression-free survival at 5 years | 5 years |
| To compare the overall survival at 5 years | 5 years |
| To compare the late toxicities between 2 treatment arms | Toxicities will be assessed by AE CTC version 4 between 2 treatment arms | 5 years |