Prostate Cancer
Conditions
Brief summary
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
Interventions
RADIATIONSBRT
DRUGAndrogen deprivation therapy (ADT)
Sponsors
VA Greater Los Angeles Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate * High-risk or unfavorable intermediate-risk as defined below: 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 * No pelvic nodal metastases (based on CT or MRI findings) * No distant metastases, based upon: 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 * Age ≥ 18 * KPS ≥ 70 (or ECOG 0-2) * Ability to understand, and willingness to sign, the written informed consent
Exclusion criteria
* Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option) * Patients with any evidence of distant metastases * Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration * Prior cryosurgery, HIFU or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn's Disease or Ulcerative Colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 5 years | progression is defined by biochemical (phoenix definition), clinical, or radiographic |
Outcome results
None listed