Status:
UNKNOWN
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04489745
Start Date
December 1 2016
End Date
January 1 2025
Last Update
July 28 2020
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