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