Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study

Garín, Olatz; Suárez, José Francisco; Guedea, Ferrán; Pont, Àngels; Pardo, Yolanda; Goñi, Alai; Mariño, Alfonso; Hervás, A.; Herruzo, Ismael; Cabrera, Patricia; Sancho, Gemma; León, Javier Ponce de; Macías, Víctor; Gutiérrez, Cristina; Castells, M.; Ferrer, M.

doi:10.1016/j.ijrobp.2020.12.032

Cited by 11 publications

(9 citation statements)

References 22 publications

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“…Acute complications and patient-reported outcomes are also included in ICHOM’s recommendations 31 . The results on survival and biochemical recurrence of the present study need to be balanced with results on patient-reported outcomes previously published 16 , showing that brachytherapy is the treatment option that causes the least negative impact. However, no single treatment can be considered the preferred strategy for managing all patients, and each treatment decision should be made jointly by patients and physicians 5 .…”

Section: Discussionmentioning

confidence: 61%

“…Study details have been described elsewhere 13 – 16 . Briefly, participants in the “Multicentric Spanish Study of Clinically Localized Prostate Cancer” were consecutively recruited from ten Spanish hospitals in 2003–2005.…”

Section: Methodsmentioning

confidence: 99%

“…Initial exclusion criteria of the cohort 13 , 14 were: treated in other hospitals than the participating centers, and previous prostate transurethral resection. According to advances in scientific evidence 17 , high risk was added to the exclusion criteria in 2011 15 , 16 . The definition by D’Amico et al 18 was used to classify patients into risk groups: T1c or T2a, PSA ≤ 10 ng/mL and Gleason ≤ 6 for low risk; and T2b, PSA 11–20 ng/mL or Gleason 7 for intermediate risk.…”

Section: Methodsmentioning

confidence: 99%

“…The definition by D’Amico et al 18 was used to classify patients into risk groups: T1c or T2a, PSA ≤ 10 ng/mL and Gleason ≤ 6 for low risk; and T2b, PSA 11–20 ng/mL or Gleason 7 for intermediate risk. Out of the 841 patients recruited, 61 were high-risk patients, 44 did not meet other inclusion criteria, 18 were transferred to other hospitals before treatment, and 14 refused to participate, giving a total of 704 participants 16 , which was the final sample included in all analyses.…”

Section: Methodsmentioning

confidence: 99%

“…This is a prospective cohort analysis of data from a project named “Multicentric Spanish Study of Clinically Localized Prostate Cancer”, composed of men diagnosed with clinically localized prostate cancer who had been followed prospectively (ClinicalTrials.gov Identifier: NCT01492751). Results of this cohort have been previously described in terms of impact of treatments’ side effects measured with patient-reported outcomes, which were the primary endpoints (at two 13 , three 14 , five 15 and ten years 16 of follow-up), but no report on mortality and biochemical recurrence has been published. The latter were a priori decided as secondary outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study

Suárez

Vigués²,

Castells³

et al. 2022

Sci Rep

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To compare the effectiveness at ten years of follow-up of radical prostatectomy, brachytherapy and external radiotherapy, in terms of overall survival, prostate cancer-specific mortality and biochemical recurrence. Cohort of men diagnosed with localized prostate cancer (T1/T2 and low/intermediate risk) from ten Spanish hospitals, followed for 10 years. The treatment selection was decided jointly by patients and physicians. Of 704 participants, 192 were treated with open radical retropubic prostatectomy, 317 with 125I brachytherapy alone, and 195 with 3D external beam radiation. We evaluated overall survival, prostate cancer-specific mortality, and biochemical recurrence. Kaplan–Meier estimators were plotted, and Cox proportional-hazards regression models were constructed to estimate hazard ratios (HR), adjusted by propensity scores. Of the 704 participants, 542 patients were alive ten years after treatment, and a total of 13 patients have been lost during follow-up. After adjusting by propensity score and Gleason score, brachytherapy and external radiotherapy were not associated with decreased 10-year overall survival (aHR = 1.36, p = 0.292 and aHR = 1.44, p = 0.222), but presented higher biochemical recurrence (aHR = 1.93, p = 0.004 and aHR = 2.56, p < 0.001) than radical prostatectomy at ten years of follow-up. Higher prostate cancer-specific mortality was also observed in external radiotherapy (aHR = 9.37, p = 0.015). Novel long-term results are provided on the effectiveness of brachytherapy to control localized prostate cancer ten years after treatment, compared to radical prostatectomy and external radiotherapy, presenting high overall survival, similarly to radical prostatectomy, but higher risk of biochemical progression. These findings provide valuable information to facilitate shared clinical decision-making.Study identifier at ClinicalTrials.gov: NCT01492751.

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Section: Discussionmentioning

confidence: 61%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study

Suárez

Vigués²,

Castells³

et al. 2022

Sci Rep

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Patientenberichtete Endpunkte – die Bedeutung der subjektiven Patientenperspektive für Forschung und klinische Versorgung

Dinkel,

Jahnen

2024

Urologie

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ZusammenfassungSymptome, Funktionsbeeinträchtigungen und die Lebensqualität können nur Patientinnen und Patienten adäquat beurteilen, die Einschätzung der Behandelnden stimmt diesbezüglich häufig nicht mit der von Betroffenen überein. Dem Rechnung tragend gewinnt die Berücksichtigung von patientenberichteten Endpunkten („patient-reported outcomes“, PROs) sowohl in der Forschung wie auch in der klinischen Routine an Bedeutung. In der praktischen Anwendung werden PROs nicht nur bei der Evaluation des Ergebnisses einer Behandlung berücksichtigt, sie können auch den Status vor einer therapeutischen Maßnahme beschreiben. Für die Erfassung der wichtigsten PROs liegen typischerweise mehrere reliable und valide Selbstbeurteilungsinstrumente vor, sog. „patient-reported outcome measures“ (PROMs). Im klinischen Alltag können PROs z. B. für die Diagnostik und Behandlungsplanung oder im Rahmen des Qualitätsmanagements genutzt werden. Das routinemäßige Patientenmonitoring mittels digitaler Medien (ePROMs) stellt gegenwärtig das vielversprechendste und am meisten beachtete Anwendungsgebiet in der klinischen Routine dar. Systematische Übersichtsarbeiten zeigen, dass die routinemäßige Erfassung von PROs u. a. mit einer Verbesserung der Arzt-Patient-Kommunikation, gesteigerter Patientenzufriedenheit, Symptombesserung, höherer Lebensqualität und einer höheren Überlebensdauer assoziiert ist. Dies gilt insbesondere dann, wenn die Ergebnisse des PRO-Monitorings an die Behandelnden zurückgemeldet werden. Trotz des inzwischen von vielen erkannten Nutzens von PROs und PROMs und der hohen Bereitschaft von Patienten, Angaben zu subjektiven Gesundheitsmerkmalen zu machen, gibt es noch zahlreiche Hürden bei deren Implementierung.

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Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26

Zamora,

Garin,

Suárez

et al. 2023

World J Urol

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Purpose To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. Methods Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach’s alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). Results The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach’s alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44–0.48 for bowel and sexual domains in patients treated with external radiotherapy. Conclusion The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

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Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study

Cited by 11 publications

References 22 publications

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study

Patientenberichtete Endpunkte – die Bedeutung der subjektiven Patientenperspektive für Forschung und klinische Versorgung

Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26

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