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Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic ablative radiotherapy | Experimental | 40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic ablative radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute GU and GI toxicities | Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0 | Baseline to 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Late GU and GI toxicities | Late GU and GI toxicities as assessed using RTOG grading schema | > 6 months post treatment |
| Quality of Life (QoL) | Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Loblaw, MD | Sunnybrook Health Sciences Centre/University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre/Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5' | Canada |
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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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| 5 years |
| Biochemical control | Biochemical disease free survival | 5 years |
| Disease free survival | Prostate biopsy 2 years post ADT cessation | 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |