Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
SBRT and ADT
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