- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864196
Two Fraction Prostate SBRT With DIL SIB
June 28, 2023 updated by: NYU Langone Health
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
49
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vianca Santos, MPH
- Phone Number: 212-496-5845
- Email: Vianca.santos@nyulangone.org
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Recruiting
- NYU Langone Hospital - Long Island
-
New York, New York, United States, 10016
- Recruiting
- NYCyberKnife at Perlmutter Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional 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
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 SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Time Frame: 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.
|
Up to year 5 Post-Treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nadir Prostate-Specific Antigen (nPSA) Levels
Time Frame: Up to Year 5 Post-Treatment
|
nPSA measured in ng/ml.
|
Up to Year 5 Post-Treatment
|
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
Time Frame: 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.
|
Baseline, Year 5 Post-Treatment
|
Incidence of Phoenix Definition Biomechanical Failure (BCF)
Time Frame: Up to Year 5 Post-Treatment
|
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)
Time Frame: Up to Year 5 Post-Treatment
|
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)
Time Frame: Up to Year 5 Post-Treatment
|
The length of time after SBRT treatment that a patient survives.
|
Up to Year 5 Post-Treatment
|
Metastasis-Free Survival (MFS)
Time Frame: 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.
|
Up to Year 5 Post-Treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Lischalk, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2033
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-01306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
Requests may be directed to: [Vianca.santos@nyulangone.org].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request.
Requests should be directed to Vianca.santos@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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