MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.
Detailed Description
Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI. Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy-proven diagnosis of prostate adenocarcinoma
- •NCCN defined low-, intermediate- and high-risk prostate cancer
- •Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion
Exclusion Criteria
- •History of prior pelvic radiation (external beam or brachytherapy)
- •Inability to undergo MRI
- •Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
- •American Urological Association (AUA) score \>17 - AUA score \>17
Outcomes
Primary Outcomes
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).
Time Frame: 2 months
Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.
Time Frame: 1month
Secondary Outcomes
- Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.(baseline, 3-6 months post treatment start)
- American Urological Association (AUA) Questionnaire Will be Assessed.(baseline, 3-6 months post treatment start)