Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Two-fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer.
NYU Langone Hospital - Long Island
Mineola, New York, United States
RECRUITINGNYCyberKnife at Perlmutter Cancer Center
New York, New York, United States
RECRUITINGNumber of Grade 2 or Higher Toxicities per CTCAE version 5.0
Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to year 5 Post-Treatment
Nadir Prostate-Specific Antigen (nPSA) Levels
nPSA measured in ng/ml.
Time frame: Up to Year 5 Post-Treatment
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
61-item assessment of quality of life in prostate cancer patients. The total score is the sum of responses and ranges from 0 to 301; higher scores indicate greater quality of life.
Time frame: Baseline, Year 5 Post-Treatment
Incidence of Phoenix Definition Biomechanical Failure (BCF)
BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).
Time frame: Up to Year 5 Post-Treatment
Disease-Free Survival (DFS)
The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.
Time frame: Up to Year 5 Post-Treatment
Overall Survival (OS)
The length of time after SBRT treatment that a patient survives.
Time frame: Up to Year 5 Post-Treatment
Metastasis-Free Survival (MFS)
The length of time after SBRT treatment that a patient is still alive and the cancer has not spread to other parts of the body.
Time frame: Up to Year 5 Post-Treatment
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