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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RECRUITING
NA
150 participants
INTERVENTIONAL
2012-06-30
2029-06-30
Brief Summary
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Detailed Description
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The protocol also includes structured follow-up and ongoing safety monitoring to track side effects, prostate-specific antigen (PSA) response, and quality-of-life outcomes. Patients are assessed at regular intervals-from two weeks post-treatment through five years-with physical exams, PSA testing, toxicity evaluations, and validated questionnaires measuring urinary and sexual function. Imaging such as prostate-specific membrane antigen (PSMA) PET/CT or bone scans is performed if biochemical failure or symptoms suggest disease progression. The study's primary goals are to determine the rate of significant gastrointestinal and genitourinary side effects and to measure biochemical disease-free survival at five years, while secondary goals include evaluating local and distant tumor control and longer-term survival outcomes. Stopping rules, adverse-event reporting procedures, and quality-assurance requirements are built into the protocol to ensure patient safety and regulatory compliance throughout the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
All participants receive the same treatment: standard external-beam radiation therapy (EBRT) plus an SBRT boost.
Stereotactic Body Radiotherapy
The intervention in this study is the SBRT boost, which is a short course of five high-dose stereotactic body radiotherapy treatments (5.5 Gy × 5 fractions, total 27.5 Gy) delivered with image-guided precision to the prostate. This SBRT boost is given in addition to standard external-beam radiation therapy (EBRT), which delivers 50.4 Gy to the pelvis, prostate, and proximal seminal vesicles.
Interventions
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Stereotactic Body Radiotherapy
The intervention in this study is the SBRT boost, which is a short course of five high-dose stereotactic body radiotherapy treatments (5.5 Gy × 5 fractions, total 27.5 Gy) delivered with image-guided precision to the prostate. This SBRT boost is given in addition to standard external-beam radiation therapy (EBRT), which delivers 50.4 Gy to the pelvis, prostate, and proximal seminal vesicles.
Eligibility Criteria
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Inclusion Criteria
* Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient.
* Clinical Stage I-IV, MX-M0 (AJCC VERSION 9)
* M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.
* Prostate volume: ≤ 100 cc (recommended not required)
* Determined using: volume = π/6 x length x height x width
* Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* No prior prostatectomy or cryotherapy of the prostate
* No prior radiotherapy to the prostate or lower pelvis
* No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
* Completion of patient questionnaires in section 3.7.
* Consent signed
Exclusion
* No prior prostatectomy or cryotherapy of the prostate
* No prior radiotherapy to the prostate or lower pelvis
* No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
18 Years
MALE
No
Sponsors
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MemorialCare Health System
OTHER
Responsible Party
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Asif Harsolia, MD
Radiation Oncologist
Principal Investigators
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Asif Harsolia, MD
Role: PRINCIPAL_INVESTIGATOR
MemorialCare
Locations
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Orange Coast Memorial Medical Center
Fountain Valley, California, United States
Saddleback Memorial Medical Center
Laguna Hills, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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065-12
Identifier Type: -
Identifier Source: org_study_id
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