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The Prostate Cancer Risk Stratification (ProCaRS) Project: Database Construction and Outcome Analysis

2012; Elsevier BV; Volume: 84; Issue: 3 Linguagem: Inglês

10.1016/j.ijrobp.2012.07.356

1879-355X

George Rodrigues, S. Gonzalez-Maldonado, Himu Lukka, Padraig Warde, Michael Brundage, Luís Souhami, Juanita Crook, Charles Catton, André‐Guy Martin, Tom Pickles,

Health Systems, Economic Evaluations, Quality of Life

Purpose/Objective(s)A pan-Canadian Prostate Cancer Risk Stratification (ProCaRS) database was commissioned by the Genitourinary Radiation Oncologists of Canada (GUROC) to report on relevant radiation therapy patient outcomes. The objective of this work is to report on the methodological construction as well as biochemical and clinical outcomes of this newly created ProCaRS database.Materials/MethodsA GUROC ProCaRS database template based on the British Columbia Cancer Agency (BCCA) cancer database was created and approved for dissemination to all Canadian investigators with potential databases for inclusion. ProCaRS template-compliant data on 7,974 radiation therapy patients was received from four institutions with a total of seven unique databases. Quality assurance and biochemical (ASTRO I/II biochemical failure-free survival - BFFS) and clinical (overall survival - OS and cancer-specific survival - CSS) outcome coding procedures were completed on October 15, 2011. Descriptive analysis of all patient, tumor, treatment, and outcomes were performed. Univariable and multivariable Cox proportional hazards and Kaplan-Meier analyses were performed.ResultsMean age was 66.5 years (SD 7.4). Mean PSA, PSA velocity, and PSA doubling time were 9.19 ng/mL (SD 11), 0.27 ng/mL/year, and 1.17 years, respectively. T stage distribution was 45.2% for T1, 46.0% for T2, 8.2% for T3, and 0.6% for T4. Gleason grade distribution was 65% for 2-6, 30% for 7, and 5% for 8-10. Mean percentage core involvement was 43%. Radiation treatment was external beam in 43% and LDR brachytherapy in 57%. HDR brachytherapy and hormonal therapy (mean 10.4 months) was utilized in 9% and 34% of patients, respectively. Median follow-up for the seven included databases ranged from 28.1 to 94.1 months (overall 71.5 months). A total of 1,230/7,974 (15%) patients died and 1,442/7,974 (19%) had ASTRO II biochemical/clinical failure. Multivariable modeling for the primary ASTRO II BFFS endpoint demonstrated that age, PSA, T stage, and Gleason score and components, hormonal therapy, and type of radiation treatment (brachytherapy > external-beam) were predictive of outcome. Kaplan-Meier analysis of the existing GUROC classification system demonstrates good separation of overall survival and ASTRO II BFFS curves.ConclusionsConstruction of a pan-Canadian prostate cancer database with a corresponding data template is feasible, can facilitate collaboration, and can inform important patient prostate cancer radiation therapy outcomes. Purpose/Objective(s)A pan-Canadian Prostate Cancer Risk Stratification (ProCaRS) database was commissioned by the Genitourinary Radiation Oncologists of Canada (GUROC) to report on relevant radiation therapy patient outcomes. The objective of this work is to report on the methodological construction as well as biochemical and clinical outcomes of this newly created ProCaRS database. A pan-Canadian Prostate Cancer Risk Stratification (ProCaRS) database was commissioned by the Genitourinary Radiation Oncologists of Canada (GUROC) to report on relevant radiation therapy patient outcomes. The objective of this work is to report on the methodological construction as well as biochemical and clinical outcomes of this newly created ProCaRS database. Materials/MethodsA GUROC ProCaRS database template based on the British Columbia Cancer Agency (BCCA) cancer database was created and approved for dissemination to all Canadian investigators with potential databases for inclusion. ProCaRS template-compliant data on 7,974 radiation therapy patients was received from four institutions with a total of seven unique databases. Quality assurance and biochemical (ASTRO I/II biochemical failure-free survival - BFFS) and clinical (overall survival - OS and cancer-specific survival - CSS) outcome coding procedures were completed on October 15, 2011. Descriptive analysis of all patient, tumor, treatment, and outcomes were performed. Univariable and multivariable Cox proportional hazards and Kaplan-Meier analyses were performed. A GUROC ProCaRS database template based on the British Columbia Cancer Agency (BCCA) cancer database was created and approved for dissemination to all Canadian investigators with potential databases for inclusion. ProCaRS template-compliant data on 7,974 radiation therapy patients was received from four institutions with a total of seven unique databases. Quality assurance and biochemical (ASTRO I/II biochemical failure-free survival - BFFS) and clinical (overall survival - OS and cancer-specific survival - CSS) outcome coding procedures were completed on October 15, 2011. Descriptive analysis of all patient, tumor, treatment, and outcomes were performed. Univariable and multivariable Cox proportional hazards and Kaplan-Meier analyses were performed. ResultsMean age was 66.5 years (SD 7.4). Mean PSA, PSA velocity, and PSA doubling time were 9.19 ng/mL (SD 11), 0.27 ng/mL/year, and 1.17 years, respectively. T stage distribution was 45.2% for T1, 46.0% for T2, 8.2% for T3, and 0.6% for T4. Gleason grade distribution was 65% for 2-6, 30% for 7, and 5% for 8-10. Mean percentage core involvement was 43%. Radiation treatment was external beam in 43% and LDR brachytherapy in 57%. HDR brachytherapy and hormonal therapy (mean 10.4 months) was utilized in 9% and 34% of patients, respectively. Median follow-up for the seven included databases ranged from 28.1 to 94.1 months (overall 71.5 months). A total of 1,230/7,974 (15%) patients died and 1,442/7,974 (19%) had ASTRO II biochemical/clinical failure. Multivariable modeling for the primary ASTRO II BFFS endpoint demonstrated that age, PSA, T stage, and Gleason score and components, hormonal therapy, and type of radiation treatment (brachytherapy > external-beam) were predictive of outcome. Kaplan-Meier analysis of the existing GUROC classification system demonstrates good separation of overall survival and ASTRO II BFFS curves. Mean age was 66.5 years (SD 7.4). Mean PSA, PSA velocity, and PSA doubling time were 9.19 ng/mL (SD 11), 0.27 ng/mL/year, and 1.17 years, respectively. T stage distribution was 45.2% for T1, 46.0% for T2, 8.2% for T3, and 0.6% for T4. Gleason grade distribution was 65% for 2-6, 30% for 7, and 5% for 8-10. Mean percentage core involvement was 43%. Radiation treatment was external beam in 43% and LDR brachytherapy in 57%. HDR brachytherapy and hormonal therapy (mean 10.4 months) was utilized in 9% and 34% of patients, respectively. Median follow-up for the seven included databases ranged from 28.1 to 94.1 months (overall 71.5 months). A total of 1,230/7,974 (15%) patients died and 1,442/7,974 (19%) had ASTRO II biochemical/clinical failure. Multivariable modeling for the primary ASTRO II BFFS endpoint demonstrated that age, PSA, T stage, and Gleason score and components, hormonal therapy, and type of radiation treatment (brachytherapy > external-beam) were predictive of outcome. Kaplan-Meier analysis of the existing GUROC classification system demonstrates good separation of overall survival and ASTRO II BFFS curves. ConclusionsConstruction of a pan-Canadian prostate cancer database with a corresponding data template is feasible, can facilitate collaboration, and can inform important patient prostate cancer radiation therapy outcomes. Construction of a pan-Canadian prostate cancer database with a corresponding data template is feasible, can facilitate collaboration, and can inform important patient prostate cancer radiation therapy outcomes.