Two Fraction Prostate SBRT With DIL SIB

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age greater than or equal 18 Localized adenocarcinoma of the prostate Biopsy-proven diagnosis of prostate adenocarcinoma Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease TX-T2c-8th addition staging PSA<20 ng/ml Grade group 3 or less Proper rectal space replacement required as determined by the treating radiation oncologist Prostate size less than 60cc defined at time of simulation based on MRI Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion -- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills Ability to give informed consent Exclusion Criteria: High risk disease Pelvic lymph node involvement Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion Prior radiation to the pelvis Prior malignancies within the last 5 years Inability to meet pre-specified 2 fraction DVH constraints Prostate size > 60cc as measures at treatment planning MRI Active significant inflammatory bowel disease (IBD) or rheumatological disease Prior prostate surgeries Previous uro lift Transurethral resection of the prostate (TURP) within 6 months of SBRT Reasonable urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (>50 overall summary score for each domain) Men of reproductive potential may not participate unless they agree to use an effective contraceptive method

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men with low to intermediate risk prostate cancer<br>Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5. | Radiation: Two-Fraction Stereotactic Body Radiation Therapy (SBRT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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. | Up to year 5 Post-Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nadir Prostate-Specific Antigen (nPSA) Levels | nPSA measured in ng/ml. | 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. | 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). | 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. | Up to Year 5 Post-Treatment | 
| Overall Survival (OS) | The length of time after SBRT treatment that a patient survives. | 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. | Up to Year 5 Post-Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife