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IIR 04-335 – HSR&D Study

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IIR 04-335
PSA Failure: A Rising Concern for Prostate Cancer
Sara J. Knight PhD
San Francisco VA Medical Center, San Francisco, CA
San Francisco, CA
Funding Period: June 2006 - November 2010

BACKGROUND/RATIONALE:
A substantial number of men diagnosed with prostate cancer (25% to 40%) will experience rising Prostate Specific Antigen (PSA) levels, what is known as biochemical recurrence, within ten years of having been treated with radical prostatectomy or radiation therapy. Currently, guidelines for treatment of men who experience biochemical recurrence (defined as a PSA rise of >0.2ng/dl on repeat testing for patients originally treated with radical prostatectomy, and either 2 rises above nadir or PSA >50% higher than nadir after radiation therapy) support the use of long-term or short-term androgen deprivation therapy (ADT) or observation. However, to date there is considerable uncertainty about the timing of ADT, and little information on real world utilization of ADT and observation. To address these questions, we sought to evaluate patterns of care and patient reported outcomes among Veterans who experienced PSA Failure and who are cared for in the VHA.

OBJECTIVE(S):
The main objectives were to document in Veterans with biochemical recurrence following primary therapy: 1) patient socio-demographic and clinical characteristics, 2) treatment management practices, 3) health related quality of life (HRQL) outcomes, 4) patient treatment preferences, and 5) treatment decision satisfaction.

METHODS:
Eligible subjects were English-speaking patients at VHA clinics and academic affiliates who received primary therapy for prostate cancer, which includes radical prostatectomy, brachytherapy, pelvic radiation, and ADT. Following initial treatment for prostate cancer, eligible patients experienced a PSA nadir and subsequent PSA rise to at least 0.2 ng/ml. Study participants were given interviewer-administered surveys on health-related QOL at baseline, 3 months, and 12 months following consent.

FINDINGS/RESULTS:
Data were collected from 206 patients at three VHA facilities and their academic affiliates. A large minority (41%) received ADT following biochemical recurrence, and the rest were managed with observation (59%). The analyses revealed variations in patterns of care across the facilities following biochemical recurrence. In a model including demographic variables and health literacy, facility and number of comorbid conditions were the only significant predictors of treatment choice. Preliminary analyses of baseline and follow-up data show few differences in health-related quality of life, cancer-specific symptoms, and prostate-specific symptoms across hormonal treatment and observation, and little change over time to the three-month assessment.

IMPACT:
Our study of patterns of care and patient-reported outcomes of care is the first to describe treatment choice and patient quality of life when PSA rises following primary treatment for localized prostate cancer, a condition known as biochemical recurrence. This research shows use of both recommended options in VHA, but practice variation across facilities. In addition, our data suggest that Veterans with biochemical recurrence have quality of life that is similar to other men of the same age in the general population regardless of choice of ADT or observation.

PUBLICATIONS:

Conference Presentations

  1. Pickard AS, Bennett C:, Hsiang-Wen L, Knight SJ, Sharifi R, Wu Z. Significant relationships between biological/clinical and self-reported measures of health in prostate cancer. Paper presented at: American Urological Association Annual Meeting; 2007 May 5; Anaheim, CA.
  2. Zagory JA, Chang C, Knight SJ, Lyons A, Bennett CL. Urinary dysfunction appears to be the primary determinant of castration versus observation for prostate cancer patients with PSA failure. Presented at: American Society of Clinical Oncology Annual Meeting; 2006 Jun 2; Atlanta, GA.


DRA: Health Systems, Cancer
DRE: Treatment - Observational
Keywords: Best Practices, Cancer, Caregivers – not professionals, Decision-Making, Outcomes - Patient, Patient Preferences, Practice Patterns/Trends, Prostate disease, Quality of life
MeSH Terms: none

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