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This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT and ADT | Experimental | Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation |
| ||
| Androgen deprivation therapy (ADT) |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | progression is defined by biochemical (phoenix definition), clinical, or radiographic | 5 years |
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Inclusion Criteria:
High-risk localized prostate cancer, as defined by any one of the following factors:
Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher.
Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors:
Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and >50% biopsy cores positive, or The presence of any two of the following: PSA>10, cT2b-c, Gleason score 3+4 in any core
CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020164 | Chemical Actions and Uses |