NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #10: NCRA /13/17 Eileen Tonner, MS

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1 NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #10: NCRA /13/17 Eileen Tonner, MS

2 Study Progress as of 6/13 Number of patients submitted as eligible: 2449 Number of sites completed with the study: 81 Number of sites still working: 743 Number of sites that have not started: 321

3 Purpose of the Study For patients who have received curative-intent prostate cancer treatment Determine whether more frequent PSA testing leads to better survival or more harm for the patient In order to answer this question, it is important to know every PSA test the patient had To know exactly how frequently a patient is having PSA tests To know if the patient has had a recurrence

4 Ineligible patients Our goal was to have each site complete 12 patients for the Special Study Monitoring for this study so far have shown a higher than expected rate of ineligible patients, so our sample size seems to be much lower than initially projected Only patients who were treated with either radical prostatectomy or radiation for prostate cancer are included

5 Changes to Eligibility We have made study modifications which are necessary to reach the projected sample size 1. Patient Eligibility Question #1: The requirement for medical records will decrease from 5 years to 3 years in the first patient level eligibility criteria question, Is there evidence that medical records are available for this patient for 5 years or until distant recurrence or death? 2. The replacement patient queue will include patients diagnosed in the years Previously, only patients diagnosed between were included in the study. These changes went into effect Tuesday, May 30 at 11:59 pm CST. Updated Instructions Version 2 is on the website and web form and will not be mailed out.

6 Changes to Eligibility New Deadline is August 28 th 2017 Sites that completed the study prior to May 30 will not be affected The patients only affect the replacement queue when a patient is submitted as ineligible Previously submitted cases will still count toward the 12 total Additional cases have already been added if the site had less than 12 patients, but sites are not required to submit more than 12 patients Individual notifications will not be sent out to a site that completed the study

7 Thank you for Asking Questions Many questions relate to is this patient eligible? What if a PCP is identified but never did PSA work up? What if the PCP s office responds but the urologist s office will not respond? PCPs may have checked PSAs, biopsies, scans, etc. It would be important to enter all of this information if the PCP checked these items that are relevant to the study The key question is: do you feel you are able to record all the PSAs a patient has had after treatment? 3 years is required for a patient to be eligible, once eligible we ask for 8 years of follow up

8 Eligibility Criteria 1) Evidence that medical records are available for the patient for 3 consecutive years or until distant recurrence or death- whichever is first 2) For patients who received primary radical prostatectomy: the patient s urologist and primary care physician can be identified For patients who received primary radiotherapy: the patient s radiation oncologist and urologist and primary care physician can be identified 3) The patients has at least 1 PSA test result within 2 years after end of primary treatment and registrar is confident in capturing PSA information for 2 years after primary treatment completion

9 Patient Eligibility If any eligibility question is answered No and is submitted, a new patient should automatically be added to the list once the page is refreshed. Please wait at least 2 weeks to hear back from outside offices for records. Please mark the patient ineligible if the outside office does not respond after multiple requests. If the patient does not have a PCP, then the patient is eligible. If you do not know if the patient has a PCP, or if the patient has a PCP but you are not able to get records, then this patient is not eligible. A complete record for 3 years is needed for patients to be eligible. However, it is possible that some patients did not have PSAs every year. Only the questions on the web form are the required information for the study Patients receiving care at the VA for prostate cancer or prostate cancer follow-up are not eligible.

10 Pathologic T and Pathologic N The web form will not allow answers to be left blank Please use FORDS 2016 pages Please code as 88 if Pathologic T and Pathologic N were not recorded instead of leaving blank Pathologic T codes shown

11 PSA Enter PSAs until time of distant recurrence or death or until the end of the surveillance period (not at biochemical recurrence) Please round results to the nearest tenth Registrars should follow the FORDS manual Example: For PSA of 1.2, the registrar can enter 012 or 12. Numerically, these are identical numbers and will not affect the study or data analysis. Except: When a patient has a result of <0.03 or <0.01 or <0.2 ( less than some number), please enter the result "0" for this special study. In this sole instance we differ from the FORDS manual, and the example was given in the instructions to specifically show this.

12 Testosterone Testosterone values of <20 pg/dl should be entered as 0. Testosterone tests might not be collected for a patient during the surveillance period.

13 Scans Scans that are clearly not related to prostate cancer or prostate cancer recurrence anywhere in the body do not need to be entered. If not sure about whether a scan should be entered, please err on the side of entering Example: Bladder scans for residual do not need to be added to scans. Only scans for purposes of detecting prostate cancer or recurrence anywhere in the body.

14 Recurrence When the doctor indicates possible recurrence and a treatment starts, this should be considered recurrence Date of recurrence should be the date of the doctor s note The term salvage radiotherapy indicates a recurrence After definitive radiation treatment, if cancer is shown in the TUR pathology, please record as a local recurrence

15 Additional Clinical Information If the pathology report states suspicious for LVI enter as No There is no response for suspicious for the study so please categorize as No Please only use the surgical pathology report. If perineural invasion was found on the biopsy report, but not the surgical pathology report, please enter No If the surgical pathology report does not mention LVI/perineural invasion, please enter unknown

16 Instructions: Special Study vs. FORDS All instructions in the Special Study Instructions Document are for the Special Study only FORDS should be used for routine data collection for the NCDB Specifically the instructions for coding biochemical recurrence and patients who are never disease free instructions differ from FORDS definitions and are only for the Special Study Do not update the NCDB with recurrence differences. We realize this is different from FORDS. If you find a patient has had a recurrence by FORDS definitions and that recurrence was not previously recorded in the NCDB, please update the patient s NCDB record with that information

17 Web form If error messages appear when using the Datalinks credentials when logging in to the web form, please use a lowercase if there is a capital in the password. Once a case is submitted as ineligible, it will automatically be replaced and will not appear on the patient list. If there are problems submitting a patient, please make sure the questions at the bottom of the PSA and Scan tabs are answered. If changes need to be made to a submitted patient specialstudy@facs.org Include Special Study IDs and FINs in communication

18 Study Communication Special Study Website: CAnswer Forum and Standards Resource Library: Please send all study-related questions to Study related questions sent to personal FACS accounts will be forwarded to the Special Study address EITHER send an through the Contact form of the website OR the address. Please do not send both as all s go to the same account. Include FINs in all communication

19 Issues s for the special study are being sent from the address through an outside server If you have not been receiving these s, send the following information to your IT department and ask them to put us on the whitelist: IP address: ,

20 NCRA Program Recognition Information Webinar #1: NCRA ; 1.0CE 4/11/17 Webinar #2: NCRA ; 1.0CE 4/18/17 Webinar #3: NCRA ; 1.0CE 4/25/17 Webinar #4: NCRA ; 1.0CE 5/02/17 Webinar #5: NCRA ; 1.0CE 5/09/17 Webinar #6: NCRA ; 1.0CE 5/16/17 Webinar #7 : NCRA ; 1.0CE 5/23/17 Webinar #8 : NCRA ; 1.0CE 5/30/17 Webinar #9 : NCRA ; 1.0CE 6/06/17 Webinar #10 : NCRA ; 1.0CE 6/13/17

21 Questions Updated Instructions Document Version 2 is available on the study website and CAnswer Forum Questions from previous webinars and the Canswer Forum will be included on all webinars Frequently Asked Questions (FAQ) document will be posted on the website, CAnswer Forum, and the web form Source:

22 Review of FAQs from Previous Webinars

23 Data Collection Q: Should data collection be stopped if the patient has a new primary? A:Please keep collecting data even if a patient has a new primary. Stop collecting data after 8 years from the surveillance start date, or until distant recurrence or death, whichever is first. Note: records do not need to be kept after the patients are submitted

24 Recurrence What should be documented when a physician states a biochemical recurrence? Please mark this as the date of first recurrence by any method. Local, regional, and distant recurrences have specific definitions in the manual

25 Recurrence 1. What PSA level should be used to classify a patient as having recurrence? We are not asking registrars to interpret PSA results Please record recurrence if clinical notes indicate recurrence, and/or if patient receives treatment for recurrence 2. Does the patient have recurrence if he was never disease free after treatment? Yes. Please record the date of first PSA test after primary treatment as date of recurrence. Never disease free can be noted as progression of disease or persistent disease after treatment

26 Recurrence Q: There is a patient that was enrolled in a clinical trial after a biochemical recurrence. How should we code clinical trial if we do not exactly know the treatment type? A: Please code as Other Types of Treatment for Recurrence.

27 What if the urologist and PCP are retired? Please see if possible to collect records from their offices. Often, physicians may have retired but records are still available All NPIs are required for each provider that saw the patient during the surveillance period If the NPI on the Surveillance tab is unknown: if there is no provider if they have the provider, but the NPI is completely unknown if it is unknown whether they have this provider.

28 NCDB Data Q: Comparing what information the NCDB tab has for a patient to what the medical record contains, there is more information available in the medical record than was initially abstracted. (i.e. Gleason on Prostatectomy and Date of Last Contact). A: Please select No and fill in the updated information. We are looking for the most current data. Please use FORDS Note: if the NCDB fields are blank, please enter the correct information. Some fields were not collected until Allowable values for Gleason Patterns are 1-5 and 9 for unknown (different from FORDS)