Each prostate-cancer treatment was associated with a distinct pattern of change in quality-of-life domains related to urinary, sexual, bowel, and hormonal function. These changes influenced satisfaction with treatment outcomes among patients and their spouses or partners.

Objectives. Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL. Methods. Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach's alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments. Results. Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r Ն0.80 and Cronbach's alpha Ն0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r Ͼ0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap. Conclusions. EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management. A s prostate cancer is increasingly diagnosed at early stages with favorable survival outcomes, the basis on which patients select primary therapy has shifted toward consideration of health-related quality of life (HRQOL). 1,2 However, no HRQOL instrument has previously been developed and validated in a setting concurrently representing each of the three most common current interventions Supported by National Institutes of Health grants 5P30CA46598 and 1P50CA69568 (National Cancer Institute Prostate Cancer Specialized Projects of Oncology Research Excellence [SPORE]), American Cancer Society Clinical Career Development Award 96-77 (M.G.S.), Robert Wood Johnson Scholars Program (J.T.W.), and American Foundation for Urological Diseases Fellowship Award (J.T.W.). From the Veterans Affairs Center for Practice Management and Outcomes Research; Ann Arbor Veterans Affairs Medical

Objectives-Widespread implementation of HRQOL measurement in prostate cancer practice and research requires concise instruments. Having 50 questions, the full-length Expanded Prostate cancer Index Composite (EPIC) is cumbersome to administer outside of studies focusing exclusively on HRQOL. To facilitate HRQOL measurement in a broad range of prostate cancer research and practice settings, we developed and validated an abbreviated version of EPIC.Methods-50 questions that comprise the full-length EPIC-50 were evaluated to identify items suitable for elimination while retaining ability to measure the 5 prostate cancer-specific HRQOL domains of EPIC-50. The resulting abbreviated version (EPIC-26) was validated using question responses from 252 subjects who had brachytherapy, external radiotherapy or prostatectomy for prostate cancer. EPIC-26 internal consistency was measured by Cronbach's alpha coefficient and reliability by test-retest correlation.Results-Based on high item-scale correlations, clinically relevant content, and preservation of domain psychometrics, 26 items were retained in EPIC-26 from 50 questions in the full length EPIC-50. High correlation was observed between EPIC-50 and EPIC-26 versions of urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domain scores (all r ≥0.96). Correlations between different domains were low, confirming that EPIC-26 retains the ability to discern 5 distinct HRQOL domains. Internal consistency and test-retest reliability for EPIC-26 (Cronbach's alpha ≥0.70 and r ≥ 0.69, respectively for all 5 HRQOL domains) support its validity.Conclusions-EPIC-26 is a brief, valid and reliable subjective measure of health quality among prostate cancer patients and suitable for measuring HRQOL among patients undergoing treatment for early stage prostate cancer.

Background TMPRSS2:ERG (T2:ERG) and prostate cancer antigen 3 (PCA3) are the most advanced urine-based prostate cancer (PCa) early detection biomarkers. Objective Validate logistic regression models, termed Mi-Prostate Score (MiPS), that incorporate serum prostate-specific antigen (PSA; or the multivariate Prostate Cancer Prevention Trial risk calculator version 1.0 [PCPTrc]) and urine T2:ERG and PCA3 scores for predicting PCa and high-grade PCa on biopsy. Design, setting, and participants T2:ERG and PCA3 scores were generated using clinical-grade transcription-mediated amplification assays. Pretrained MiPS models were applied to a validation cohort of whole urine samples prospectively collected after digital rectal examination from 1244 men presenting for biopsy. Outcome measurements and statistical analysis Area under the curve (AUC) was used to compare the performance of serum PSA (or the PCPTrc) alone and MiPS models. Decision curve analysis (DCA) was used to assess clinical benefit. Results and limitations Among informative validation cohort samples (n = 1225 [98%], 80% from patients presenting for initial biopsy), models incorporating T2:ERG had significantly greater AUC than PSA (or PCPTrc) for predicting PCa (PSA: 0.693 vs 0.585; PCPTrc: 0.718 vs 0.639; both p < 0.001) or high-grade (Gleason score >6) PCa on biopsy (PSA: 0.729 vs 0.651, p < 0.001; PCPTrc: 0.754 vs 0.707, p = 0.006). MiPS models incorporating T2:ERG score had significantly greater AUC (all p < 0.001) than models incorporating only PCA3 plus PSA (or PCPTrc or high-grade cancer PCPTrc [PCPThg]). DCA demonstrated net benefit of the MiPS_PCPTrc (or MiPS_PCPThg) model compared with the PCPTrc (or PCPThg) across relevant threshold probabilities. Conclusions Incorporating urine T2:ERG and PCA3 scores improves the performance of serum PSA (or PCPTrc) for predicting PCa and high-grade PCa on biopsy. Patient summary Incorporation of two prostate cancer (PCa)-specific biomarkers (TMPRSS2:ERG and PCA3) measured in the urine improved on serum prostate-specific antigen (or a multivariate risk calculator) for predicting the presence of PCa and high-grade PCa on biopsy. A combined test, Mi-Prostate Score, uses models validated in this study and is clinically available to provide individualized risk estimates.

During a 4-year interval from earlier to longer-term phases of PC treatment survivorship, sexual, urinary, and bowel dysfunction remain significant concerns among early-stage PC treatment survivors, compared with control men. Although postprostatectomy HRQOL remains relatively stable during this interval, disease-specific HRQOL continues to evolve among men treated with BT and 3-D CRT.