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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2023-07-17
2030-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
NCT04997018
Single Fractions SBRT for Prostate Cancer
NCT04004312
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
NCT05754580
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
NCT01540994
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
NCT00941915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Men with low to intermediate risk prostate cancer
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.
Two-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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Two-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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Lischalk
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYCyberKnife at Perlmutter Cancer Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-01306
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.