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TRANSCRIPT
COMPPARE Workshop 2020
A Patient-Centric Prospective Comparative Study of Outcomes of Proton and Photon Radiation Therapy in Men with Prostate Cancer
January 17-19, 2020Amelia Island, Florida
1. Emory University (Atlanta, GA)2. Johns Hopkins University (Baltimore, MD)3. Karmanos Cancer Institute at McLaren (Flint, MI)4. Mayo Clinic (Jacksonville, FL)5. Oregon Health & Science University (Portland,
OR)6. Thomas Jefferson University (Philadelphia, PA)7. University of Chicago (Chicago, IL)8. Duke University (Durham, North Carolina)9. Sutter Health (Sacramento, CA)10. Texas Oncology (Longview, TX and Sherman, TX)
Participating Sites (Photon)
11. University of California San Diego (San Diego, CA)12. UF Health (Gainesville, FL)13. UNC-REX Hospital (Raleigh, NC)14. University of Arizona (Tucson, AZ)15. University of Louisville (Louisville, KY)16. University of Miami School of Medicine (Miami, FL)17. University of Virginia Health System (Charlottesville
City, VA)18. University of Kansas (Lawrence, KS)19. University of Oklahoma ( Norman, OK)20. Cleveland Clinic (Cleveland, OH)21. Weill Cornell Medicine College (New York, NY)
Activated Sites are in Red.
1. Ackerman Cancer Center- Radiation Oncology (Jacksonville, FL)
2. California Protons: Proton Radiation Therapy Cancer Treatment Center (San Diego, CA)
3. University of Maryland School of Medicine (Baltimore, MD)
4. Hampton University PTI (Hampton, VA)5. Procure PTC (Somerset, NJ)6. Mayo Clinic PTC (Rochester, MN)7. Mayo Clinic PTC (Scottsdale, AZ)8. MD Anderson Cancer Center Mays Clinic (Houston, TX)9. MGH Francis H. Burr PTC (Boston, MA)10. Miami Cancer Institute- Baptist Health South Florida
(Miami, FL)11. Northwestern Medicine Chicago PTC: Chicago Cancer
Care (Warrenville, IL)12. Orlando Health UF Health Cancer Center- PTC (Orlando,
FL)
13. Rutgers Cancer Institute of New Jersey (New Brunswick, NJ) 14. S. Lee Kling PTC / Washington University (St. Louis, MO)15. Seattle Cancer Care Alliance affiliated with the University of
Washington (Seattle, WA)16. Texas Center for Proton Therapy (Irving TX)17. Provision Healthcare: Proton Therapy Center (Knoxville,TN)18. UH Seidman Cancer Center at Case Western (Cleveland, OH)19. University of Pennsylvania (Philadelphia, PA)20. University of Cincinnati Medical PTC (Cincinnati, OH)21. James M. Slater, MD Proton Treatment & Research Center (Loma
Linda, CA)22. University of Florida Proton Therapy Institute (Jacksonville, FL)23. New York Proton (New York, NY)24. Willis Knighton PTC (Shreveport, LA)
Activated Sites are in Red.
Participating Sites (Proton)
Enrollment Updates
SITE DAYS ACTIVATED
TOTAL ANTICIPATED ENROLLMENT
CURRENT ENROLLMENT
UFHPTI 556 225 204 GVILLE 360 45 26 Provision 244 100 5 UPenn 244 96 19 Procure 238 25 10 U Chicago 173 20 2 Ackerman 138 97 1 New York Proton 138 75 3 Orlando Health 138 15 0 Northwestern 102 110 2 Loma Linda 138 250 8 Mayo Jacksonville 136 20 3 Mayo MN 136 60 13 California Proton 123 46 13 Emory 123 10 3 Rutgers 69 20 1 MD Anderson 24 300 0 MGH 24 50 0 Miami Cancer Center 39 10 0
Willis-Knighton 33 46 0 Thomas Jefferson 48 60 0 University of Miami 24 30 0
UNC-Rex 38 25 0 University of Maryland 24 25 3
Karmanos 31 37 0 Washington University 33 30 1
University of Cincinnati 39 30 0
Seattle Cancer Care Alliance- University of Washington
21 50 0
Texas Oncology 24 45 0 Texas Proton 24 30 0 TOTAL 1782 317
Current Photon Enrollments
14%(45)
Current Pragmatic Proton Enrollments
52%(164)
Current RCT Proton Enrollments
34%(108)
Current Enrollments
26
5
1910
2 3 8 13 13
945
29
38
4835
8
53
117
7
1710
2 9
75
133
12 158 6 3 9 7 8 13 8 11
0
20
40
60
80
100
120
140
UF Healt
h
Provision Health
care
Univ of P
ennsylvan
ia
Procure PTC
Univ of C
hicago
Ackerm
an Cancer Center
New York Proton Center
Orlando Health
PTC
Northweste
rn Medicin
e Chicago
PTC
Loma Lin
da (JA Sla
ter)
Mayo Clin
ic (Ja
cksonvill
e, FL)
Mayo Clin
ic PTC (R
ochester, M
N)
California Protons
Emory Unive
rsity
Rutgers
Cancer In
stitute
MD Anderson CC
MGH Francis
H. Burr P
TC
Miami C
ancer In
stitute
Willis Knighton PTC
Thomas Jeffe
rson
Universi
ty of M
iami
Rex Hospita
l-UNC
Maryland PTC
Karmanos C
ancer In
stitute
S. Lee Klin
g PTC
/ Washington Univ.
Univ. of C
incinnati M
edical P
TC
Seattle
Cancer Care
Alliance
Texas Center fo
r Proton Th
erapy
Texas Onco
logy
Activated Site Patient Enrollments and Goals through 5/1/20
Total enrollment to date (n=317) Remaining enrollment goals (n=641)As of 01/13/20.
COMPPARE Cohorts
Physican and patient determine
radiation type
Protons * pre-screen eligibility
Randomized (RCT) Consent
Pragmatic Proton Consent
Photons*pre-screen eligibility
Pragmatic Photon Consent Only
• There are two consents:• Randomized Proton Consent
• Offer first• If patient does not want to be randomized, offer non-randomized study.• If a patient withdraws consent but wishes to stay in the pragmatic study, patient must be re-
consented using the non-randomized consent.• Non-Randomized Consent
• Photon and proton • If your site treats both modalities, be sure to indicate which treatment the patient will receive.
• Upload consents into VTOC as soon as possible, but no later than the last business day of the month the participant consented.• Sites must keep the original consent.• Document that consent is obtained in accordance with GCP and the ICF
is dated prior to the participant’s participation on the study.
Consents
Randomization Schema
Randomized (RCT) Consent
Eligibility Verification
Randomized to Arm 1:Standard Proton Therapy
78.0 Gy(RBE) in 39 fractions
Randomized to Arm 2:Hypofractionated Proton
Therapy Therapy 60.0 Gy(RBE) in 20 fractions
Recommended Pragmatic Schemes- Proton and Photon
Standard fractionation:• 1.8 Gy (RBE) fractions to ≥77.4 – 86.0 Gy (RBE)• 2.0 Gy (RBE) fractions to ≥78 - 82 Gy (RBE)
Moderate hypofractionation: • 2.4 Gy (RBE) fractions to 72 Gy (RBE)• 2.5 Gy (RBE) fractions to 70 Gy (RBE) or 72.5 Gy (RBE)• 3.0 Gy (RBE) fractions to 60 Gy (RBE)• 3.1 Gy (RBE) fractions to 62 Gy (RBE)
*See section 12.5.5.1 Table G of the Protocol for additional dose fractionations
• Research Staff at each site will maintain a log of patients prescreened and reasons patients are not approached or refuse consent.• Any prostate patient that was not approached or did not consent to the study • Email to the Coordinating Center on the 1st business day of each month• This is required for all participating sites; it is not optional.
• If you did not pre-screen patients, please let the Coordinating Center know why for reporting purposes.• If a patient is on the log & then consents to the study, please
remove them from the log after they consent.
Pre-Screening log
Pre-Screening log Tips & TricksOnly fill out one of the 3 columns shown below• If the patient is not approached for reasons other than ineligibility, then fill out “Reason
not approached”• If a patient is ineligible, skip “Reason not approached” & only fill out “Reason for
ineligibility”• If an eligible patient is approached about the study but refuses – please fill out “Reason
for refusal”• If one of the provided drop-downs does not cover the reason for either not approach,
ineligibility, or refusal, please select “Other” and add additional information in the “Comments” column
Pre-Screening log Tips & Tricks
Pre-Screening log Tips & Tricks• Column K: Comments• Add additional clarifying comments if needed• For example, if a patient was not approached because he is pending additional
testing results before determining eligibility, comments explaining that can be placed here• If a reason is not captured in one of the provided drop-down selections for the
columns of Not approached, Ineligibility, or Refusal, please select other & list the reason in this column.
Vision Tree Optimal Care (VTOC)
Before Treatment
• Clinical Forms• Pre-Treatment Evaluation
Form, Study Entry Form, Prostate Lab and ADT Form
• Baseline Standard Interview Assessment Form*
• Patient Forms• EPIC, IPSS, PRO-CTCAE and
Pretreatment Patient Survey
During Treatment
• Clinical Forms• Weekly/ on-treatment
Standard Interview Assessment Form
• Participant Payment Form• Reporting AEs, SAEs or
Deviations
• Patient Forms• Weekly PRO-CTCAE
Follow-Up
• Clinical Forms• Physics Treatment Planning
Summary• Standard Interview
Assessment Form• Prostate Lab and ADT form• Reporting AEs, SAEs or
Deviations
• Patient Forms• 3 month QOLs• Annual QOLS
COMPPARE Forms
COMPPARE Baseline Standard Interview*
Regardless of the 3 options you select: on the Assessment and Event Form you must select from the drop down menu the Form Type and On Treatment then Start of Treatment.
Day before or first day of RT
BestNear CT Sim
2nd
Best After RT but during first week
3rd Best 2nd week of
RT or later
NO
3 month
• +/- 30 days
• Required items• AE Tox Assessment-
Standard Interview Form
• Patient questionnaires: EPIC, IPSS, PRO-CTCAE
• Optional Item*• PSA
6 month
• +/- 30 days
• Optional Items• AE Tox Assessment-
Standard Interview Form
• PSA*• If not done at 3
month MUST be done at 6 month
Annual
• +/- 45 days• 1, 2 and 3 years
• Required items• AE Tox Assessment-
Standard Interview Form
• PSA• Patient
questionnaires: EPIC, IPSS, PRO-CTCAE
18 month
• Required items• PSA
Follow-up COMPPARE Forms
Consent
• Create Study Entry Form- complete up to Inclusion/Exclusion fields• Complete Pre-treatment Form and Prostate Lab and ADT form• Upload Consent and Source Documents
Email Coordinating
Center
• Allow 4 days for Clinical Data Rapid Review• Queries
Register patient
• Once Clinical Data Rapid Review Approval Email received
Clinical Data Rapid Review 1st 3 patients of each modality
Clinical Data Rapid Review Tips & Tricks
Source
• Original labs for PSA*• Original Imaging*• Original Pathology*
• Histology
Commonly Missed Source
• Quartile of Health• DRE• Race and Ethnicity• Medications• ADT
Common Errors
• ACE must be from clinician (MD/PA/APRN)
• Prostate Volume can be found on TRUS, MRI or DRE
• Path Grid: NS- leave PNI and HPGIN blank
• Listing Life Expectancy without documenting Quartile of Health
• Family History: if not mentioned in Notes, leave blank
• ADT not entered Lab Form
*Consult or Encounter Note will not be accepted
Consent
• Create Study Entry Form- complete up to Inclusion/Exclusion fields• Upload Consent*
Verify Eligibility
• Complete Pre-treatment Form and Prostate Lab and ADT
Register patient
• Once eligibility is verified
Rapid Reviews Completed4th Photon or Proton patient
*Upload consents into VTOC as soon as possible, but no later than the last business day of the month participant consented
How to Register a PatientEnter all the
Inclusion and Exclusion criteria on
the Study Entry Form
Is the patient eligible? will auto populate once
all of the inclusion/exclusion
criteria questions have been completed
Enter Date of Registration
Yes or No is entered for ‘Participant
agree to Randomization’
If ‘Yes’ is selected: ‘Will this patient receive pelvic
nodal irradiation? ‘‘No’ must be answered
Saved, and closed on the Study Entry
Form.
The assigned COMPPARE ID will auto populate at
the bottom of form.
Reopen the form to see the assigned COMPPARE ID and/or randomization
allocation
Examples
Releasing QOLs
Fixing Errors in VTOC
Monitoring
• Website www.COMPPARE.org• Enrollment • Patient Newsletter Subscription
• Consortium Team Materials • Protocol• Study and VTOC manuals • Recruitment Materials
Resources
https://comppare.org/about/videos/
Payments
Patient completed:• Pre-treatment
QOLs• At least 1
weekly QOL
3rd visit or later On Study Entry
Form• Required• No
Abbreviations• Complete #
SSN Participant Payment Form• Correct Proxy
ID • Package ID
field
VTOC Form 3 years
• Funds issued to same card after completing 3 month and annual QOLs
Keep Card