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15 appendix c follow-up evaluations

Surveillance ARM - PROSTVAC: surveillance for 6 months followed by vaccinia-PROSTVAC, 2x108 infectious units  
subcutaneously in week 1 and fowlpox-vaccine 1x109 infectious units subcutaneously given in week 3, week 5 and then monthly for a  
total of 6 months of treatment. After this 6-month treatment period is complete, patiens will then have the option of fowlpox-vaccine  
1x109 q 3 months for 1 year while in follow-up).  
Screening/  
Baseline11 Surveillance for 6 months 1 cycle = 28 days; C=Cycle; D=Day  
M -6 M -5 M-4 M-3 M-2 M-1 C1  
D1  
C1 D15  
C2 D1  
C3 D1  
C4 D1  
C5 D1  
C6 D1  
C7 D1  
C8 D1  
C9+  
D16,7  
End of study  
| 1x109  q 3 months for 1 year while in follow-up). Screening/  Baseline11 Surveillance for 6 months                                          | 1 cycle = 28 days; C=Cycle; D=Day   |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------|-----|-----|-----|----|----|----|-------|-------|----|----|----|----|-----|--------|
| M -6                                                                                                                                        | M -5                                | M-4       | M-3 | M-2 | M-1 | C1 | C1 | C2 | C3    | C4    | C5 | C6 | C7 | C8 | C9+ | End of |
| D1                                                                                                                                          | D15                                 | D1        | D1  | D1  | D1  | D1 | D1 | D1 | D16,7 | study |    |    |    |    |     |        |
| Informed Consent / Registration                                                                                                             | X                                   |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| Randomization                                                                                                                               | X                                   | TREATMENT |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| rV-PROSTVAC                                                                                                                                 | X                                   |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| rF-PROSTVAC                                                                                                                                 | X                                   | X         | X   | X   | X   | X  | X9 |    |       |       |    |    |    |    |     |        |
| EVALUATION                                                                                                                                  |                                     |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| History and PE, Height  and Weight                                                                                                          | X                                   | X         | X   | X   | X   | X  | X  | X  | X     | X     | X  | X  | X1 | X  |     |        |
| ECOG Performance  Score                                                                                                                     | X                                   |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| Pathologic confirmation  of dx                                                                                                              | X2                                  |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| Laboratory Testing CBC with differential                                                                                                    | X                                   | X         | X   | X   | X   | X  | X  | X  | X     | X     | X1 | X  |    |    |     |        |
| Serum chemistries (Na+,  K+, Cl-, CO2, glucose, BUN,  creatinine, albumin, calcium, alkaline phosphatase,  ALT, AST, total bilirubin, LDH,) | X                                   | X         | X   | X   | X   | X  | X  | X  | X     | X     | X1 | X  |    |    |     |        |
| CK, uric acid, total protein,                                                                                                               | X                                   |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |
| magnesium, phosphorus,                                                                                                                      |                                     |           |     |     |     |    |    |    |       |       |    |    |    |    |     |        |  
| Screening/  Baseline11               | Surveillance for 6 months   | 1 cycle = 28 days; C=Cycle; D=Day   |     |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
|--------------------------------------|-----------------------------|-------------------------------------|-----|-----|-----|----|----|----|-------|-------|----|----|----|----|-----|--------|----|----|
| M -6                                 | M -5                        | M-4                                 | M-3 | M-2 | M-1 | C1 | C1 | C2 | C3    | C4    | C5 | C6 | C7 | C8 | C9+ | End of |    |    |
| D1                                   | D15                         | D1                                  | D1  | D1  | D1  | D1 | D1 | D1 | D16,7 | study |    |    |    |    |     |        |    |    |
| Urinalysis                           | X                           |                                     |     |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Serum PSA and  Testosterone          | X                           | X                                   | X   | X   | X   | X  | X  | X  | X     | X     | X  | X  | X  | X  | X   | X      | X1 | X  |
| Hep B/HepC, HIV                      | X3                          |                                     |     |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Lymphocyte  Phenotyping  (CD4/CD8)12 | X                           | X                                   | X   | X   | X   | X  | X  | X  | X     | X     | X1 | X  |    |    |     |        |    |    |
| PAP (prostatic acid  phosphatase)    | X                           | X                                   | X   | X   | X   | X  | X  | X  | X     | X     | X  | X  |    |    |     |        |    |    |
| ECG                                  | X5                          |                                     |     |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Tc 99 scintigraphy                   | X4                          | X                                   | X6  |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
| CT-C/A/P, or MRI                     | X4                          | X                                   | X6  |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Research Bloods                      | X                           | X                                   | X   | X   | X7  | X8 |    |    |       |       |    |    |    |    |     |        |    |    |
| FACT- P survey10                     | X10                         | X10                                 | X10 | X10 | X10 |    |    |    |       |       |    |    |    |    |     |        |    |    |
| MSK Anxiety Survey10                 | X10                         | X10                                 | X10 | X10 | X10 |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Adverse Events                       | X                           | X                                   | X   | X   | X   |    |    |    |       |       |    |    |    |    |     |        |    |    |
| Concomitant  Medications             | X                           | X                                   |     |     |     |    |    |    |       |       |    |    |    |    |     |        |    |    |
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footnotes

1 HPE, CBC, Chem, PSA, and Lymphocyte Phenotyping will be obtained every cycle. For week 3 and week 5, these tests can be done +/- 3 days and for cycle 3 to cycle 6, they can be done +/- 14 days for logistical reasons. Vaccine can be given +/- 3 days for week 3 and week 5 and for cycle 3 to cycle 6, it can be given +/- 14 days for logistical reasons. Research blood will be drawn +/- 3 days for C1D1, C2D1 and +/- 14 days for C6D1 and C9D1 for logistical reasons.  
2 Pathologic confirmation will be obtained any time prior to enrollment 3 HepB/HepC/HIV status will be obtained within 8 weeks prior to enrollment 4 Screening Tc99 sctintigraphy and CT-CAP or MRI will be obtained within 8 weeks prior to enrollment 5 Baseline ECG will be obtained within 8 weeks prior to enrollment 6 Restaging will be done every 6 months (+/- 14 days) or earlier if clinically indicated. If, however, in the opinion of the investigator re-staging scans are not required (in patients with a PSA DT > 6 months over the previous 6 months) then re-staging scans can be deferred, document in chart to assure compliance. However, once PSA DT is less than 6 months, scans must be performed.) Re-staging scans may exclude CT Chest.  
7 Patients will continue to be followed after Cycle 9 until progression or ADT is clinically indicated. All visits will include evaluations listed for cycle 9 except research blood. Research blood will not be drawn after Cycle 9.  
8optional 9Patients will have the option to initiate 1 year of vaccine maintenance within 3 months of cycle 6 vaccine, administered every 12 weeks. This year will include follow-up every 6 weeks during this period for PSA checks on non-vaccine visits. (Patients seen every 6 weeks during 1 year maintenance period). Patients will be required to have a PSADT greater than 5 months, as measured over the prior 6 months in order to start and continue vaccine during the 1 year maintenance period.  
10Surveys are optional at all time points and can be done every 3 months for the first 9 months and every 3-4 months therafter while patients are on-study. (If surveys are not done, reason will be documented.)
11 Refer to sections 2.2 for screening evaluation and 2.4 for baseline evaluation 12 Not performed at DFCI site. -All patient visits can be delayed by 2 weeks for logistical issues except for week 3 and 5 where the window is 3 days.  
Immediate Vaccine ARM– PROSTVAC (vaccinia-PROSTVAC, 2x108 infectious units subcutaneously in week 1 and fowlpoxvaccine 1x109 infectious units subcutaneously given in week 3, and week 5, then monthly for a total of 6 months of treatment. After  
this 6-month treatmentperiod is complete, patiens will then have the option of fowlpox-vaccine 1x109 q 3 months for 1 year))  
Screening/  
Baseline11  
Treatment 1 cycle = 28 days; C=Cycle; D=Day  
| this 6-month treatmentperiod is complete, patiens will then have the option of fowlpox-vaccine 1x109  q 3 months for 1 year))  Screening/ Treatment 1 cycle = 28 days; C=Cycle; D=Day Baseline11 C1 C1 C2 C3 C4 C5 C6 C7 C8 C9+ End of  D1 D15 D1 D1 D1 D1 D1 D1 D1 D16,7  study  Informed Consent / Registration X Randomization X TREATMENT rV-PROSTVAC X rF-PROSTVAC X X X X X X X9 EVALUATION History and PE, Height  and Weight X X X X X X X X X X1 X ECOG Performance  Score X X2 Pathologic confirmation of dx Laboratory Testing CBC with differential X X X X X X X X X X1 X Serum chemistries(Na+,  K+, Cl-, CO2, glucose, BUN,  creatinine, albumin, calcium,  magnesium, phosphorus, alkaline  phosphatase, ALT, AST, total  bilirubin, LDH.  X X X X X X X X X X1 X CK, uric acid, total protein,  X magnesium, phosphorus, Urinalysis X Serum PSA and  Testosterone X X X X X X X X X X X1 X Hep B/HepC, HIV X3   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| Screening/                           | Treatment   | 1 cycle = 28 days; C=Cycle; D=Day   |     |     |    |    |    |    |       |       |        |    |
|--------------------------------------|-------------|-------------------------------------|-----|-----|----|----|----|----|-------|-------|--------|----|
| Baseline11                           | C1          | C1                                  | C2  | C3  | C4 | C5 | C6 | C7 | C8    | C9+   | End of |    |
| D1                                   | D15         | D1                                  | D1  | D1  | D1 | D1 | D1 | D1 | D16,7 | study |        |    |
| Lymphocyte  Phenotyping  (CD4/CD8)12 | X           | X                                   | X   | X   | X  | X  | X  | X  | X1    | X     |        |    |
| PAP (prostatic acid  phosphatase)    | X           | X                                   | X   | X   | X  | X  | X  | X  | X     | X     | X      | X  |
| Research bloods                      | X           | X                                   | X   | X7  | X8 |    |    |    |       |       |        |    |
| ECG                                  | X5          |                                     |     |     |    |    |    |    |       |       |        |    |
| FACT- P survey10                     | X10         | X10                                 | X10 | X10 |    |    |    |    |       |       |        |    |
| MSK Anxiety Survey10                 | X10         | X10                                 | X10 | X10 |    |    |    |    |       |       |        |    |
| Tc 99 scintigraphy                   | X4          | X6                                  |     |     |    |    |    |    |       |       |        |    |
| CT-C/A/P, or MRI                     | X4          | X6                                  |     |     |    |    |    |    |       |       |        |    |
| Adverse Events                       | X           |                                     |     |     |    |    |    |    |       |       |        |    |
| Concomitant  Medications             | X           |                                     |     |     |    |    |    |    |       |       |        |    |  
1HPE, CBC, Chem, PSA, and Lymphocyte Phenotyping will be obtained every cycle including maintenance vaccine dosing. For week 3 and week 5, these tests can be done +/- 3 days and for cycle 3 to cycle 6, they can be done +/- 14 days for logistical reasons. Vaccine can be given +/- 3 days for week 3 and week 5 and for cycle 3 to cycle 6, it can be given +/- 14 days for logistical reasons. Screening labs within 16 days can be used for C1D1 serum PSA, testosterone, and PAP. Research blood will be drawn +/- 3 days for C2D1 and +/- 14 days for C6D1 and C9D1 days for logistical reasons.  
2 Pathologic confirmation will be obtained anytime prior to enrollment 3 HepB/HepC/HIV status will be obtained within 8 weeks prior to enrollment 4 Screening Tc99 sctintigraphy and CT-CAP or MRI will be obtained within 8 weeks prior to enrollment 5 Baseline ECG will be obtained within 8 weeks prior to enrollment 6 Restaging will be done every 6 months (+/- 14 days) or earlier if clinically indicated. If, however, in the opinion of the investigator re-staging scans are not required (in patients with a PSA DT > 6 month over the previous 6 months, document in chart to assure compliance) then re-staging scans can be deferred. However, once PSA DT is less than 6 months, scans must be performed.) Re-staging scans may exclude CT Chest. 7 Patients will continue to be followed after Cycle 9 until progression or ADT is clinically indicated. All visits will include evaluations listed for cycle 9 except research blood. Research blood will not be drawn after Cycle 9..  
8optional 9 Patients will have the option to initiate 1 year of vaccine maintenance within 3 months of cycle 6 vaccine, administered every 12 weeks. This year will include follow-up every 6 weeks during this period for PSA checks on non-vaccine visits. (Patients seen every 6 weeks during 1 year maintenance period). Patients will be required to have a PSADT greater than 5 months, as measured over the prior 6 months in order to start and continue vaccine during the 1 year maintenance period.  
10Surveys are optional at all time points and can be done every 3 months for the first 9 months and every 3-4 months therafter while patients are on-study. (If surveys are not done, reason will be documented.)
11 Refer to sections 2.2 for screening evaluation and 2.4 for baseline evaluation 12 Not performed at DFCI site.  
-All patient visits can be delayed by 2 weeks for logistical issues except for week 3 and 5 where the window is 3 days.
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16 appendix d instructions for

| Blood Studies                                                                                  | Blood Tube/Comments      | Destination                                 |
|------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------|
| CBC with differential                                                                          | 1 light lavender tube    | CC Department of  Laboratory Medicine (DLM) |
| Hepatic Panel, Mineral Panel,  Acute Care Panel, LDH, CK,  Uric Acid, Total Protein            | 1 4 mL SST               | CC DLM                                      |
| Anti-HIV-1/2                                                                                   | 1 8 mL SST               | CC TTV lab                                  |
| Testosterone, total                                                                            | 1 red top tube           | CC DLM                                      |
| Prostate Specific Antigen                                                                      | 4 mL SST                 | CC DLM                                      |
| Lymphocyte Phenotyping,  TBNK (Optional based on  site. Required at NCI but not  MSK or DFCI.) | 1 light lavender tube    | CC DLM                                      |
| Immunology Assays                                                                              | 6 10 mL Na Heparin tubes | NCI-Frederick                               |
| 2 8 ml SST tubes                                                                               | 1-301-846-5893           |                                             |  
| 17                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | APPENDIX E: CCR PROBLEM REPORT FORM                                                                |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| NCI Protocol #:                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Protocol Title:  Report version: (select one) ____Initial Report  ____Revised Report ____Follow-up |
| Site Principal Investigator:                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                    |
| Date of problem:                                                                                                                                                                                                                                                                                                                                                                                                                                                              | Location of problem: (e.g., patient's home,  doctor's office)                                      |
| Who identified the problem? (provide role (not name of person): nurse, investigator,  monitor, etc…) Brief Description of Subject (if  applicable)  Sex: ___ Male ___ Female Age:  ___ Not applicable (more than subject is involved) (Do NOT include personal  identifiers) Diagnosis under study:  Name the problem: (select all that apply)  [ ] Adverse drug reaction  [ ] Abnormal lab value  [ ] Death  [ ] Cardiac Arrest/ code  [ ] Anaphylaxis  [ ] Sepsis/Infection |                                                                                                    |  
[ ] Blood product reaction [ ] Unanticipated surgery/procedure [ ] Change in status (e.g. increased level of care required) [ ] Allergy (non-medication) [ ] Fall [ ] Injury/Accident (not fall) [ ] Specimen collection issue [ ] Informed consent issue
[ ] Ineligible for enrollment
[ ] Breach of PII [ ] Tests/procedures not performed on schedule [ ] Other, brief 1-2 word description: _________________________
Detailed Description of the problem: (Include any relevant treatment, outcomes or pertinent history):
*Is this problem unexpected? *(see the definition of unexpected in the protocol))* __YES __NO Please explain:
*Is this problem related or possibly related to participation in the research?  
__YES __NO Please explain:
*Does the problem suggest the research places subjects or others at a greater risk of harm than was previously known or recognized? __YES __NO
Please explain:
Is this problem? (*select all that apply*)
[ ] An Unanticipated Problem* that is: [ ] Serious [ ] Not Serious [ ] A Protocol Deviation that is: [ ] Serious [ ] Not Serious [ ] Non-compliance *Note if the 3 criteria starred above are answered, "YES", then this event is also a UP.  
Is the problem also *(select one)* [ ] AE [ ] Non-AE Have similar problems occurred on this protocol at your site? __YES __NO If "Yes", how many? ____ Please describe:
Describe what steps you have already taken as a result of this problem:
In addition to the NCI IRB, this problem is also being reported to: (select all that apply)
[ ] Local IRB [ ] Study Sponsor [ ] Manufacturer : ____________________ [ ] Institutional Biosafety Committee [ ] Data Safety Monitoring Board [ ] Other: ____________________________________ [ ] None of the above, not applicable INVESTIGATOR'S SIGNATURE: DATE:
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18 appendix f instructions for

PBMCS: 6 green top (Na heparin, 10 mL) tubes, BD Vacutainer Ref \#366480 Serum: 2 red serum separator (8 mL) tubes, Greiner Bio-One Vacutainer Ref \#455071
* Blood is collected at 4 time points (with an optional 5th **time point in Arm B)**: baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1. In addition, an end of study research blood draw can be done at the discretion of the investigator and based on logistics for willing patients.
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shipping

PBMCs are to be sent on the day of draw; serum is to be frozen and batch-shipped at intervals. NCI does not provide lab kits/shipping supplies. Please send samples using generic ambient (PBMCs) and dry ice (serum) Category B sample shippers, and include a completed transmittal form (blank form provided) with each shipment. Please ship FedEx Overnight using FedEx account number 251310645. **Please note, PBMCs cannot be shipped within 72 hours after a bone scan or MUGA scan injection due to the Technetium-99 radioisotope or within 24 hours after a Sodium Fluoride PET scan injection due to the Fluorine-18 radioisotope. If a bone scan, MUGA scan, or PET scan (or other nuclear medicine study) is scheduled, PBMCs must be drawn prior to injection of radioisotopes. 1) Pack blood vials in Category B shipping materials (EXAKT-PAK as described below or equivalent): For ambient PBMCs: EXAKT-PAK for Vials Category B D-Pak MD8702V06 (Accommodates 6 vials) Includes Inner pack (Ambient) and Insulated Cooler With 2 cool packs per cooler, part \#CP1003, room temperature or slightly cooled (not frozen) to keep samples between 18 and 30oC.  
For frozen serum: EXAKT-PAK Frozen Category B D-Pak MD8703V06 Dry ice required (not included) 2) Send email notification of upcoming shipment, and include completed transmittal or manifest with shipment.  
- Emails should be sent to the following individuals:
Theresa Burks, burkst@mail.nih.gov Myrna Rauckhorst, mrauckhorst@mail.nih.gov Caroline Jochems, jochemscm@mail.nih.gov Ravi Madan, madanr@mail.nih.gov 3) Ship **FedEx Overnight** using FedEx account number **251310645**. 4) NO specimens should be shipped on Fridays or the day before a Federal holiday.
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shipping address

Leidos Biomedical Research, Inc. Attn: Theresa Burks 1050 Boyles Street Bldg. 469/Room 121 Frederick, MD 21702 Phone 301-846-5125, or 301-846-1707
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paperwork/labeling

- Please label research tubes with a coding mechanism. The following information should be contained on the label:
site name  
patient enrollment number (provided by the Central Registration Office upon registration/randomization) and initials  
arm - list whether patient is randomized to Arm A or Arm B NCI protocol \#16-C-0035 Date Drawn Time point - list sample as either baseline, C1D1, C2D1, D6D1, or C9D1 Example:
Site name - 01-ABC–Arm A Protocol \# NCI 16-C-0035 Date Drawn: 08/01/2015 Time point: baseline
- Please complete a transmittal form for each PBMC timepoint and include with sample shipment. Blank transmittal form will be provided. For batch-shipped serum, please provide an Excel spreadsheet manifest listing all included samples. Information that should be listed on the manifest includes Subject ID, Sample ID, Sample Type (i.e. serum), Collection Date/Time, Study Day, Number of Vials, and any Comments.
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shipping supplies

NCI does not provide lab kits/shipping supplies. Please send samples using generic ambient (PBMCs) and dry ice (serum) Category B sample shippers (such as EXAKT-PAK or equivalent).  
EXAKT-PAK supplies available at: https://www.exaktpak.com/store/ EXAKT Technologies, Inc. Home office: 7002 N. Broadway Extension Oklahoma City, OK 73116-9006 405-848-5800
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19 appendix g sample form

ATTN: Ms. Theresa Burks/ Leidos-Frederick, Attn: CML 469/121, Bldg 1050 Boyles Street, Frederick MD 21702, Phone 301-846-5125 PROJECT ID: 001.016.0039.0003 CSAS: 21682 SOURCE CODE: SD007 PROTOCOL: 16-C-0035 Prostvac in Patients with Biochemical Recurrent Prostate Cancer. Sample from external center (*insert Site Name here*)
INVESTIGATOR: Ravi Madan, M.D. CONTACT: Jennifer Marte, 301-480-0276, martej@mail.nih.gov RESEARCH NURSE: Myrna Rauckhorst RN, 240-760-7971, page 102-14681, mrauckhorst@mail.nih.gov BACK-UP CONTACT: Caroline Jochems, 301-402-6274 or 496-4343; jochemscm@mail.nih.gov RESEARCH INFORMATION: 16-C-0035 Patient enrollment \# + initials + arm: _________________
ADDITIONAL SAMPLE INFORMATION (Time point, Cycle, etc.) : _______
DATE SAMPLE DRAWN: ___________________ DATE SAMPLE PROCESSED: _______________________
**LAB USE ONLY**  
  
Kopp Lab SAMPLE DESCRIPTION: **16C0035 + Pt. Enrollment \# +3 pts initials+Arm \#**
Fisher Biosciences Repository Input Sample Description: CCMM number + 16-C-0035 PROCESSING OR TESTING REQUESTED ON FRESH SAMPLE: Check all that apply:
Cryopreservation: __X___ Updated 9-27-17
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version date 5.30.18 appendix h

YOUR FEELINGS ABOUT PROSTATE CANCER AND PROSTATE SPECIFIC ANTIGEN TESTS We would like to better understand how patients cope with aspects of their treatment for prostate cancer and the medical tests frequently involved in their care.  
| I. Below is a list of comments made by men about prostate cancer. Please indicate by circling the number next to each item how frequently these comments were true for   |            |           |                   |       |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------|-------------------|-------|
| you during the past week; not at all, rarely, sometimes, often.                                                                                                          | Not at all | Rarely    | Sometimes         | Often |
| 1. Any reference to prostate cancer brought up strong                                                                                                                    |            |           |                   |       |
| feelings in me.                                                                                                                                                          | 0          | l         | 2                 | 3     |
| 2. Even though it's a good idea, I found that getting a                                                                                                                  |            |           |                   |       |
| PSA test scared me.                                                                                                                                                      | 0          | l         | 2                 | 3     |
| 3. Whenever I heard about a friend or public figure                                                                                                                      |            |           |                   |       |
| with prostate cancer, I got more anxious about my                                                                                                                        |            |           |                   |       |
| having prostate cancer.                                                                                                                                                  | 0          | l         | 2                 | 3     |
| 4. When I thought about having a PSA test, I got more                                                                                                                    |            |           |                   |       |
| anxious about my having prostate cancer.                                                                                                                                 | 0          | l         | 2                 | 3     |
| 5. Other things kept making me think about prostate                                                                                                                      | 0          | l         | 2                 | 3     |
| cancer.                                                                                                                                                                  |            |           |                   |       |
| 6. I felt kind of numb when I thought about prostate                                                                                                                     | 0          | !         | 2                 | 3     |
| cancer.                                                                                                                                                                  |            |           |                   |       |
| 7. I thought about prostate cancer even though I didn't                                                                                                                  |            |           |                   |       |
| mean                                                                                                                                                                     | 0          | !         | 2                 | 3     |
| 8. I had a lot of feelings about prostate cancer, but I                                                                                                                  |            |           |                   |       |
| didn't want to deal with them.                                                                                                                                           | 0          | 1         | 2                 | 3     |
| 9. I had more trouble falling asleep because I couldn't                                                                                                                  |            |           |                   |       |
| get thoughts of prostate cancer out of my mind.                                                                                                                          | 0          | l         | 2                 | 3     |
| 10. I was afraid that the results from my PSA test would                                                                                                                 |            |           |                   |       |
| show that my disease was getting worse.                                                                                                                                  | 0          | !         | 2                 | 3     |
| 1. Just hearing the words "prostate cancer" scared me.                                                                                                                   | 0          | l         | 2                 | 3     |
| I. For the next three questions, please indicate how frequently these situations have EVER been true for you.                                                            |            |           |                   |       |
| Not at all                                                                                                                                                               | Rarely     | Sometimes | Often             |       |
| 12. I have been so anxious about my PSA test that I                                                                                                                      |            |           |                   |       |
| have thought about delaying it.                                                                                                                                          | 0          | l         | 2                 | 3     |
| 13. I have been so worried about my PSA test result                                                                                                                      |            |           |                   |       |
| that I have thought about asking my doctor to                                                                                                                            |            |           |                   |       |
| repeat it.                                                                                                                                                               | 0          | l         | 2                 | 3     |
| 14. I have been so concerned about my PSA test result                                                                                                                    |            |           |                   |       |
| that I have thought about having the test repeated                                                                                                                       |            |           |                   |       |
| at another lab to make sure they were accurate.                                                                                                                          | 0          | !         | 2                 | 3     |
| I. Listed below are a number of statements concerning a person's beliefs about their own health. In thinking about the past week, please indicate how much you agree or  |            |           |                   |       |
| disagree with each statement: strongly agree, agree, disagree, or strongly disagree. Please circle the number of your answer.                                            |            |           |                   |       |
| Strongly agree                                                                                                                                                           | Agree      | Disagree  | Strongly disagree |       |
| 15. Because cancer is unpredictable, I feel I cannot                                                                                                                     |            |           |                   |       |
| plan for the future.                                                                                                                                                     | 0          | !         | 2                 | 3     |
| 16. My fear of having my cancer getting worse gets in                                                                                                                    |            |           |                   |       |
| the way of my enjoying life.                                                                                                                                             | 0          | l         | 2                 | 3     |
| 17. I am afraid of my cancer getting worse.                                                                                                                              | 0          | !         | 2                 | 3     |
| 18. I am more nervous since I was diagnosed with                                                                                                                         |            |           |                   |       |
| prostate cancer                                                                                                                                                          | 0          | 2         | 3                 |       |
| l                                                                                                                                                                        |            |           |                   |       |
| PSA: prostate specific antigent                                                                                                                                          |            |           |                   |       |  
Version Date: 5.30.18
untitled h1
fact-p survey

Below is a list of statements that other people with your illness have said are important. Please circle or mark one number per line to indicate your response as it applies to the past 7 days.  
| Not                                                         | A little                                                       | Some-    | Quite   | Very   |      |    |
|-------------------------------------------------------------|----------------------------------------------------------------|----------|---------|--------|------|----|
| PHYSICAL WELL-BEING                                         | at all                                                         | bit      | what    | a bit  | much |    |
| GP1                                                         | I have a lack of energy                                        | 3        |         |        |      |    |
| 0                                                           | l                                                              | 2        | 4       |        |      |    |
| 2                                                           | 3                                                              |          |         |        |      |    |
| GP2                                                         | I have nausea                                                  | 0        | l       | 4      |      |    |
| Because of my physical condition, I have trouble            |                                                                |          |         |        |      |    |
| GP3                                                         | meeting the needs of my family .                               | 0        | l       | 2      | 3    | 4  |
| gn                                                          | I have pain                                                    | 0        | l       | 2      | 3    | 4  |
| GPS                                                         | I am bothered by side effects of treatment .                   | 0        | l       | 2      | 3    | 4  |
| GP6                                                         | I feel ill .                                                   | 0        | l       | 2      | 3    | 4  |
| GP7                                                         | I am forced to spend time in bed .                             | 0        | l       | 2      | 3    | 4  |
| SOCIAL/FAMILY WELL-BEING                                    | Not                                                            | A little | Some-   | Quite  | Very |    |
| at all                                                      | bit                                                            | what     | a bit   | much   |      |    |
| GS1                                                         | I feel close to my friends .                                   | l        | 2       | 3      | 4    |    |
| 0                                                           |                                                                |          |         |        |      |    |
| GS2                                                         | I get emotional support from my family .                       | l        | 2       | 3      | 4    |    |
| 0                                                           |                                                                |          |         |        |      |    |
| I get support from my friends.                              | 2                                                              | 3        |         |        |      |    |
| G                                                           | 0                                                              | l        | 4       |        |      |    |
| My family has accepted my illness                           | 2                                                              | 3        |         |        |      |    |
| GS4                                                         | 0                                                              | l        | 4       |        |      |    |
| I am satisfied with family communication about my           |                                                                |          |         |        |      |    |
| gss                                                         | illness                                                        | 0        | l       | 2      | 3    | 4  |
| GS6                                                         | I feel close to my partner (or the person who is my main       |          |         |        |      |    |
| support) .                                                  | 0                                                              | l        | 2       | 3      | 4    |    |
| Regardless of your current level of sexual activity, please |                                                                |          |         |        |      |    |
| Ql                                                          | answer the following question. If you prefer not to answer it, |          |         |        |      |    |
| please mark this box                                        | and go to the next section.                                    |          |         |        |      |    |
| I am satisfied with my sex life                             | 2                                                              | 3        |         |        |      |    |
| GS7                                                         | 0                                                              | l        | 4       |        |      |    |  
| GEI   |
|-------|
| GE2   |
| GE    |
| GE4   |
| GES   |
| GES   |  
Version Date: 5.30.18
untitled h1
functional well-being

Not Quite  
| A little   | Some-   |
|------------|---------|
| bit        | what    |  
Very much a bit  
| EMOTIONAL WELL-BEING                                          | Not   | A little   | Some-   | Quite   | Very   |
|---------------------------------------------------------------|-------|------------|---------|---------|--------|
| at all                                                        | bit   | what       | a bit   | much    |        |
| I feel sad .                                                  | 0     | l          | 2       | 3       | 4      |
| 2                                                             |       |            |         |         |        |
| I am satisfied with how I am coping with my illness.......... | 0     | l          | 3       | 4       |        |
| 2                                                             |       |            |         |         |        |
| I am losing hope in the fight against my illness              | 0     | l          | 3       | 4       |        |
| I feel nervous .                                              | 0     | l          | 2       | 3       | 4      |
| 2                                                             |       |            |         |         |        |
| I worry about dying                                           | 0     | l          | 3       | 4       |        |
| 2                                                             |       |            |         |         |        |
| I worry that my condition will get worse .                    | 0     | l          | 3       | 4       |        |  
at all GF1  
| I am able to work (include work at home) .              | 0   |
|---------------------------------------------------------|-----|
| My work (include work at home) is fulfilling .          | 0   |
| I am able to enjoy life                                 | 0   |
| I have accepted my illness                              | 0   |
| I am sleeping well .                                    | 0   |
| I am enjoying the things I usually do for fun           | 0   |
| I am content with the quality of my life right now…………. | 0   |  
GF2 GF3 GF4 GF5 GF6 GF1 4  
| 2   |
|-----|
| 2   |
| 2   |
| 2   |
| 2   |
| 2   |
| 2   |  
| 3   |
|-----|
| 3   |
| 3   |
| 3   |
| 3   |
| 3   |
| 3   |  
4 4 4 4 4 4  
| l   |
|-----|
| l   |
| l   |
| l   |
| l   |
| l   |
| l   |  
| ADDITIONAL CONCERNS             | Not at                                                                   | A little   | Some-   | Quite   | Very   |    |
|---------------------------------|--------------------------------------------------------------------------|------------|---------|---------|--------|----|
| all                             | what                                                                     | a bit      |         |         |        |    |
| bit                             | much                                                                     |            |         |         |        |    |
| C2                              | I am losing weight                                                       | 0          | l       | 2       | 3      | 4  |
| C                               | I have a good appetite .                                                 | 0          | l       | 2       | 3      | 4  |
| r                               | I have aches and pains that bother me.                                   | 0          | l       | 2       | 3      | 4  |
| P2                              | I have certain parts of my body where I experience pain....              | 0          | l       | 2       | 3      | 4  |
| P3                              | My pain keeps me from doing things I want to do .............            | 0          | 2       | 3       | 4      |    |
| l                               |                                                                          |            |         |         |        |    |
| P4                              | I am satisfied with my present comfort level ........................... | 2          | 3       |         |        |    |
| 0                               | l                                                                        | 4          |         |         |        |    |
| P5                              | I am able to feel like a man .                                           | 2          |         |         |        |    |
| 0                               | l                                                                        | 3          | 4       |         |        |    |
| I have trouble moving my bowels |                                                                          |            |         |         |        |    |
| PS                              | 0                                                                        | l          | 2       | 3       | 4      |    |
| P7                              | I have difficulty urinating.                                             | 0          | l       | 2       | 3      | 4  |
| BL2                             | I urinate more frequently than usual .                                   | 0          | l       | 2       | 3      | 4  |
| PS                              | My problems with urinating limit my activities                           | 0          | l       | 2       | 3      | 4  |
| BLS                             | I am able to have and maintain an erection............................   | 0          | l       | 2       | 3      | 4  |