Medical Affairs and Health Economics and Outcomes Research, R

1
Medical Affairs and Health Economics and
Outcomes Research, RDTAP Pharmaceutical
Products Inc.
CaPSURE Cancer of the
Prostate
Strategic
Urologic Research
Endeavor
2
Objectives

• Description of CaPSURE
• Purpose and Objectives
• Background
• Key Components
• Current Capabilities
• Research and Benchmarking
• Research Scholars Program

3
CaPSURE Description

• A national disease registry of approximately
  12,000 men with prostate cancer since 1995
• 31 sites of both community and academic
  participate
• CaPSURE is one of the oldest patient registries
  for any disease in the country
• Data includes clinical, economic and quality of
  life
• Data is reported from physicians and patients
• Data is available for benchmarking and research
  purposes

4
CaPSURE Website www.capsure.net
5
CaPSURE Objectives

• Collect longitudinal information on cohort of
  patients with prostate cancer
• Describe existing and emerging patterns and
  outcomes of care
• Identify predictive variables of health outcomes

6
How is CaPSURE Different from other registries?

• Majority of data comes from community practices,
  not academic centers (CPDR and SEARCH)
• Tracks usual care, not clinical trial outcomes
• Patient self-report of quality-of-life data is
  primary component of study outcomes
• Provides urologists data for benchmarking and
  research

7
Participating Research Sites

• 40 sites ever participated
• 31 current active core research sites
• Urology practices only
• Community-based
• Academic medical centers
• Veterans Administration (VA)
• Sites located in 27 states
• CaPSURE is currently closed to enrolling new
  sites

8
Location of CaPSURE Sites
9
Data Collection

• Clinical data collected at diagnosis and at each
  subsequent office visit
• Patient self-report using questionnaires
  administered at baseline and every 6 months
• Administrative data is collected on an ongoing
  basis
• Data integrated and verified by UCSF

10
Types of Data Collection

• Patient Self-Report
• Background Information
• Serial Questionnaires
• Quality of Life
• Resource Use
• Satisfaction
• Case Mix

• Clinical Data
• Medical History
• Progress Note (each encounter)
• Laboratory and Pathology
• Medications
• Surgical Procedures

• Administrative
• Patient Study Status
• Hospital Audits
• Death Follow-up

11
Clinical Variables

• Screening results (PSA and DRE)
• Disease stage (clinical and pathological)
• Method(s) of diagnosis and staging
• All treatments (including drugs)
• PSA levels (total and free)
• Medical and surgical history
• Margin status on RP specimen

12
Quality of Life Variables

• Health-related quality of life
• SF-36 (general)
• UCLA Prostate Cancer Index (disease- specific)
• Satisfaction with care and treatment
• Symptoms and side effects

13
Economic Variables

• Demographics at baseline
• Co morbidity checklist at baseline
• Healthcare resource utilization
• Worker productivity

14
Independent Data Sources

• Data are collected from
• Hospital audits medical records
• Death certificate data vital statistics
• Surgical pathology reports

15
Major Outcomes

• 66 published scientific papers in the following
  areas
• Review Article- 3
• Clinical Outcomes 38
• Health-related Quality of Life - 20
• Research methodology 4
• Economics of care 3
• 132 scientific abstracts presented at
  professional meetings

16
CaPSURE Research

• Data from the CaPSURE registry is available upon
  request for research purposes
• Data is provided free of charge to researchers
• Applications for data to answer specific research
  questions are available at www.capsure.net

17
No relationship between diabetes and
agressiveness of PCA or risk of recurrence

• Issue Past research suggested a protective
  effect of diabetes on development of prostate
  cancer
• Research Data from 2780 men with localized
  disease who underwent RP monotherapy as primary
  treatment and 546 men who underwent external beam
  or brachytherapy radiation were analyzed
• Findings No association between clinical
  features of PC and diabetes status
• Men with DM were 50 more likely to undergo
  external beam radiation or hormonal therapy (63)
  vs. RP. No difference in WW or brachytherapy by
  DM status
• No difference in recurrence for DM vs. non-DM
  patients with RP

18
No relationship between diabetes and
agressiveness of PCA or risk of recurrence

• Among all men receiving radiation, after
  adjustment of all factors (demographics, body
  size,clinical etc.), the overall rate of
  recurrence did not differ between patients with
  diabetes and those without diabetes
• However, men who were younger at prostate cancer
  diagnosis risk, having diabetes was associated with a 2-4
  fold increased hazard of recurrence after
  radiation.
• More work is required to understand relationships
  between DM and Pca outcomes.

Cancer Causes and Control 16789,2005
19
The UCSF Cancer of the Prostate Risk Assessment
Score

• Problem Many Pca nomograms available (Kattan,
  Damico). Some are more difficult to use and
  calculate, others are not accurate or detailed in
  risk stratification
• UCSF CAPRA is easier to use to estimate Pca
  disease recurrence as defined by a PSA .2 ng/ml
  greater on 2 consecutive occasioins following
  prostatectomy or a second cancer treatment more
  than 6 months after surgery
• Conclusion Each 2 point increase in CAPRA score
  doubles risk of recurrence. RFS at 5 years ranged
  from 85 for CAPRA of 0-1, to 8 for CAPRA of
  7-10. May be a useful tool for patient education
  and treatment planning

J. Urology1731938-1942, 2005
20
(No Transcript)
21
(No Transcript)
22
(No Transcript)
23
Use of complementary and alternative medicine use
is significant in Pca patients

• Problem Past research shows high percentage of
  Pca patients taking CAM supplementation. Little
  information on specific CAM in Pca patients
• CaPSURE research surveyed patients on 52 item CAM
  survey from 1999 to present. 2582 patients who
  completed at least 2 surveys within 2 years of
  diagnosis were evaluated for CAM usage

24
(No Transcript)
25
CAM use in Pca Patients

• Patients were were college educated, earned
  higher incomes (30K/yr), had multiple
  co-morbidities or a higher biopsy Gleason score
  (worse tumor grade) and living in West were more
  likely to use CAM
• Conclusion More research required on benfits of
  CAM in treatment of prostate cancer.

26
CaPSURE Scholars Program

• CaPSURE is a training opportunity
• Infrastructure and expertise in place to support
  from UCSF
• In 2005, 7 scholars produced abstracts which were
  accepted to 2006 AUA and other Prostate Cancer
  Meetings

27
Questions?