Prostate Cancer
Conditions
Keywords
Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife
Brief summary
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.
Interventions
RADIATIONTwo-Fraction Stereotactic Body Radiation Therapy (SBRT)
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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Grade 2 or Higher Toxicities per CTCAE version 5.0 | Up to year 5 Post-Treatment | Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nadir Prostate-Specific Antigen (nPSA) Levels | Up to Year 5 Post-Treatment | nPSA measured in ng/ml. |
| Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score | Baseline, Year 5 Post-Treatment | 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. |
| Incidence of Phoenix Definition Biomechanical Failure (BCF) | Up to Year 5 Post-Treatment | BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA). |
| Disease-Free Survival (DFS) | Up to Year 5 Post-Treatment | The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer. |
| Overall Survival (OS) | Up to Year 5 Post-Treatment | The length of time after SBRT treatment that a patient survives. |
| Metastasis-Free Survival (MFS) | Up to Year 5 Post-Treatment | 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. |
Countries
United States
Contacts
CONTACTVianca Santos, MPH
PRINCIPAL_INVESTIGATORJonathan Lischalk
NYU Langone Health
Outcome results
None listed