Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery
NCT ID: NCT02446366
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2015-05-12
2023-02-12
Brief Summary
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Detailed Description
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I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (\< 90 days).
SECONDARY OBJECTIVES:
I. To describe the acute (\< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
II. To describe the late (\> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
TERTIARY OBJECTIVES:
I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment.
OUTLINE: This is a dose-escalation study.
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (hypofractionated SBRT)
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Stereotactic Body Radiation Therapy
Undergo hypofractionated SBRT
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Stereotactic Body Radiation Therapy
Undergo hypofractionated SBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy
* One of the following pathologic classifications
* T3N0 disease with or without a positive surgical margin or
* T2N0 disease with or without a positive surgical margin
* Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or
* Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
* Zubrod performance status of 0 -1
* No distant metastases, based on the following workup within 60 days prior to registration
* Magnetic resonance imaging (MRI) of the pelvis
* Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis
* Patients can be on androgen deprivation therapy
* Ability to understand and willingness to sign a study-specific informed consent prior to study entry
Exclusion Criteria
* Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
* Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
* Prior radiation of any kind to the prostate gland or pelvis
* Prior brachytherapy is not allowed
* History of inflammatory colitis or other active severe comorbidities
* Patients who are on immunosuppressant medication
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Leslie Ballas
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31.
Other Identifiers
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NCI-2015-00296
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-14-8
Identifier Type: OTHER
Identifier Source: secondary_id
4P-14-8
Identifier Type: -
Identifier Source: org_study_id