Back to resultsStereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SBRT
Androgen deprivation therapy (ADT)
Sponsored by
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
Arm Type
Experimental
Arm Label
SBRT and ADT
Arm Description
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
Outcomes
Primary Outcome Measures
progression free survival
progression is defined by biochemical (phoenix definition), clinical, or radiographic
Secondary Outcome Measures
Full Information
NCT ID
NCT04489745
First Posted
July 23, 2020
Last Updated
July 23, 2020
Sponsor
VA Greater Los Angeles Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT04489745
Brief Title
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Greater Los Angeles Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT and ADT
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Type
Drug
Intervention Name(s)
Androgen deprivation therapy (ADT)
Primary Outcome Measure Information:
Title
progression free survival
Description
progression is defined by biochemical (phoenix definition), clinical, or radiographic
Time Frame
5 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
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