Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pencil Beam Scanning Proton SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Biopsy-proven NCCN low- or intermediate-risk prostate cancer, which includes patients with:
- Gleason score ≤7 disease
- PSA ≤20 ng/ml
Clinical T1-T2c disease
- Note: Patients who only have radiographic evidence of possible or probable T3 disease (i.e., extracapsular extension or seminal vesical invasion) will not be excluded.
- KPS ≥ 80%
- Prostate size as determined on MRI to be < 100 cc. Prostate size can be determined on CT scan if MRI is not available.
- Male 18 years of age or older
- IPSS ≤ 20
- Patient must be a candidate for and agree to placement of intraprostatic fiducial markers and a hydrogel rectal spacer
- Patient must be available for at least 2 years of follow-up
Exclusion Criteria:
Prior prostate surgery (including cryosurgery)
- Note: Patients who underwent TURP or greenlight PVP are eligible if it was > 12 weeks prior to the anticipated start date of SBRT
- Prior history of chronic prostatitis or urethral stricture
- Currently active cancer(s) other than non-melanoma skin cancers. Patients are not considered to have currently active cancers if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 2 years.
- Life expectancy of < 2 years
Sites / Locations
- The New York Proton CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapy
Arm Description
Outcomes
Primary Outcome Measures
1. Grade 3+ GU/GI toxicity-free rate determined by CTCAE v5.0 grading.
The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Secondary Outcome Measures
1. Patient reported urinary symptoms determined by IPSS.
The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause LUTS. The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an additional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.
2. Patient reported urinary, bowel, and hormonal quality of life determined by EPIC-26.
EPIC-26 is the "Expanded Prostate Cancer Index Composite" patient reported outcomes questionnaire. A clinical tool to assess urinary, bowel, sexual and vitality health. The score from each of the 5 domains runs from 0 (none) to 12 (severe) impact on quality of life. Each domain score when added together gives an overall score of zero (unaffected) to 60 (severely affected)
3. Patient reported financial toxicity determined by COST
Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy (COST-FACIT) was developed as part of a series of questionnaires aimed at measuring different symptom indexes of health-related quality of life in patients with advance disease such as cancer. The survey contains 12 questions and each of them is rated from 0 (not at all) to 4 (very much). This survey focuses on financial distress caused by illness in patients with cancer. It takes about 5 minutes to complete.
4. 2-year and 5-year biochemical progression free survival
Biochemical failure is defined as a sustained rise in PSA of 2 ng/mL or more above the nadir (the lowest PSA level after radiotherapy).
5. 2-year local control determined by MRI and biopsies
6. 2-year and 5-year metastasis free survival
7. 2-year and 5-year prostate cancer specific survival
8. 2-year and 5-year overall survival
9. Dosimetric advantages determined by target coverage, conformality, and normal tissue sparing
Full Information
NCT ID
NCT04842890
First Posted
March 15, 2021
Last Updated
October 18, 2023
Sponsor
The New York Proton Center
1. Study Identification
Unique Protocol Identification Number
NCT04842890
Brief Title
Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
Official Title
Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The New York Proton Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary endpoint is 2-year grade 3+ GU/GI toxicity free rate by CTCAE v5.0, which is expected to be ≥95%. Toxicity will be evaluated by the treating radiation oncologist at least once during SBRT, then following SBRT at 1, 3, 6, 12, 18, and 24 months. The treatment will be considered safe if grade 3 or higher GU/GI toxicity free rate at 2 years is >85% (95% rate expected with a 10% non-inferiority margin). The accrual goal is 61 patients over 3 years. To ensure that unexpected significant toxicity is identified, all grade 3 or higher toxicities will be reported to the study PI and the trial will stop accruing if at any point 4 or more patients experience a grade 3 or higher toxicity after completing SBRT. This is felt to be conservative given the vast experience with photon SBRT at this dose with an expected G3+ toxicity of ~5%.
Secondary objectives are to examine patient-reported urinary, gastrointestinal, sexual, and financial outcomes using IPSS, EPIC-26, and COST questionnaires at the same follow-up timepoints as above. Baseline measures of these domains will be obtained prior to treatment as well. Clinical outcomes will also be evaluated with PSA measured at each follow-up, as well as prostate MRI and biopsies at 2 years. Patients will be followed for at least 2 years to determine rates of PSA relapse, salvage treatment, development of metastases, death from prostate cancer, and overall survival. A dosimetric comparison will be performed where each patient will be planned for proton and photon SBRT to determine possible advantages of proton SBRT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapy
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Pencil Beam Scanning Proton SBRT
Intervention Description
The intervention being investigated is ultra-hypofractionated, image-guided, pencil beam scanning proton SBRT directed at the prostate gland and seminal vesicles to 40 Gy equivalent in 5 fractions, delivered every other day.
Primary Outcome Measure Information:
Title
1. Grade 3+ GU/GI toxicity-free rate determined by CTCAE v5.0 grading.
Description
The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
1. Patient reported urinary symptoms determined by IPSS.
Description
The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause LUTS. The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an additional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.
Time Frame
2 years
Title
2. Patient reported urinary, bowel, and hormonal quality of life determined by EPIC-26.
Description
EPIC-26 is the "Expanded Prostate Cancer Index Composite" patient reported outcomes questionnaire. A clinical tool to assess urinary, bowel, sexual and vitality health. The score from each of the 5 domains runs from 0 (none) to 12 (severe) impact on quality of life. Each domain score when added together gives an overall score of zero (unaffected) to 60 (severely affected)
Time Frame
2 years
Title
3. Patient reported financial toxicity determined by COST
Description
Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy (COST-FACIT) was developed as part of a series of questionnaires aimed at measuring different symptom indexes of health-related quality of life in patients with advance disease such as cancer. The survey contains 12 questions and each of them is rated from 0 (not at all) to 4 (very much). This survey focuses on financial distress caused by illness in patients with cancer. It takes about 5 minutes to complete.
Time Frame
2 years
Title
4. 2-year and 5-year biochemical progression free survival
Description
Biochemical failure is defined as a sustained rise in PSA of 2 ng/mL or more above the nadir (the lowest PSA level after radiotherapy).
Time Frame
2 years and 5 years
Title
5. 2-year local control determined by MRI and biopsies
Time Frame
2 years
Title
6. 2-year and 5-year metastasis free survival
Time Frame
2 years and 5 years
Title
7. 2-year and 5-year prostate cancer specific survival
Time Frame
2 years and 5 years
Title
8. 2-year and 5-year overall survival
Time Frame
2 years and 5 years
Title
9. Dosimetric advantages determined by target coverage, conformality, and normal tissue sparing
Time Frame
2 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-proven NCCN low- or intermediate-risk prostate cancer, which includes patients with:
Gleason score ≤7 disease
PSA ≤20 ng/ml
Clinical T1-T2c disease
Note: Patients who only have radiographic evidence of possible or probable T3 disease (i.e., extracapsular extension or seminal vesical invasion) will not be excluded.
KPS ≥ 80%
Prostate size as determined on MRI to be < 100 cc. Prostate size can be determined on CT scan if MRI is not available.
Male 18 years of age or older
IPSS ≤ 20
Patient must be a candidate for and agree to placement of intraprostatic fiducial markers and a hydrogel rectal spacer
Patient must be available for at least 2 years of follow-up
Exclusion Criteria:
Prior prostate surgery (including cryosurgery)
Note: Patients who underwent TURP or greenlight PVP are eligible if it was > 12 weeks prior to the anticipated start date of SBRT
Prior history of chronic prostatitis or urethral stricture
Currently active cancer(s) other than non-melanoma skin cancers. Patients are not considered to have currently active cancers if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 2 years.
Life expectancy of < 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Holder, BS
Phone
646-968-9055
Ext
387
Email
research@nyproton.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Organizational Affiliation
The New York Proton Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shaakir Hasan, DO
Organizational Affiliation
The New York Proton Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Proton Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Choi, MD
Phone
646-968-9031
Ext
303
Email
ichoi@nyproton.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer
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