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Two Fraction Prostate SBRT With DIL SIB

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Hospital - Long IslandRecruiting
  • NYCyberKnife at Perlmutter Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Men with low to intermediate risk prostate cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nadir Prostate-Specific Antigen (nPSA) Levels
nPSA measured in ng/ml.
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.
Incidence of Phoenix Definition Biomechanical Failure (BCF)
BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).
Disease-Free Survival (DFS)
The length of time after SBRT treatment that a patient survives without any signs or symptoms of cancer.
Overall Survival (OS)
The length of time after SBRT treatment that a patient survives.
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.

Full Information

First Posted
May 9, 2023
Last Updated
June 28, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05864196
Brief Title
Two Fraction Prostate SBRT With DIL SIB
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer,SBRT,Radiation Treatment,CyberKnife, SBRT, Radiation Treatment, CyberKnife

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Men with low to intermediate risk prostate cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Two-Fraction Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
Description
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
Secondary Outcome Measure Information:
Title
Nadir Prostate-Specific Antigen (nPSA) Levels
Description
nPSA measured in ng/ml.
Time Frame
Up to Year 5 Post-Treatment
Title
Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score
Description
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
Title
Incidence of Phoenix Definition Biomechanical Failure (BCF)
Description
BCF classified as a rise by 2 ng/mL or more in nadir PSA (nPSA).
Time Frame
Up to Year 5 Post-Treatment
Title
Disease-Free Survival (DFS)
Description
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
Title
Overall Survival (OS)
Description
The length of time after SBRT treatment that a patient survives.
Time Frame
Up to Year 5 Post-Treatment
Title
Metastasis-Free Survival (MFS)
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vianca Santos, MPH
Phone
212-496-5845
Email
Vianca.santos@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Lischalk
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
NYCyberKnife at Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Two Fraction Prostate SBRT With DIL SIB

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