Is There A Relationship Between Patient-Reported Outcomes (Pros) And Clinical Outcomes In Metastatic Castration-Resistant Prostate Cancer (Mcrpc) Post-Docetaxel?

Traina, Shana; Li, T; Johnson, K; KF, Ho; Molina, Antonio Morey; Cella, David

doi:10.1016/j.jval.2015.09.1244

Cited by 2 publications

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“…30 Several previous studies show that HRQoL scores can be prognostic for survival in prostate cancer. 16,[31][32][33] The prognostic value of HRQoL may reflect patient experience beyond conventional clinical characteristics. In the current study, evaluable OS data at the time of data cut-off were not yet mature, with only 28% of expected deaths (n=596).…”

Section: Discussionmentioning

confidence: 99%

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial

Tombal

Saad

Penson

et al. 2019

The Lancet Oncology

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Background In the phase 3, double-blind, placebo-controlled PROSPER trial of patients with non-metastatic castration-resistant prostate cancer, enzalutamide significantly improved metastasis-free survival (primary endpoint). Here, we report the results of patient-reported outcome (PRO) measures of this study. Methods Patients ≥18 years of age with non-metastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of ≤10 months were randomised (2:1) via interactive voice/web recognition system to receive enzalutamide (160 mg/day) or placebo. Randomisation was stratified by prostate-specific-antigen-doubling time (<6 months vs ≥6 months) and baseline use of a bone-targeting agent (yes or no). The primary endpoint was metastasis-free survival (MFS), reported elsewhere. Exploratory endpoints, reported here, included pain progression and health-related quality of life (HRQoL), assessed by the Brief Pain Inventory Short Form (BPI-SF), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25), the Functional Assessment of Cancer Therapy-Prostate (FACT-P), and the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale (EQ-VAS). Patients completed questionnaires at baseline, Week 17, and every 16 weeks thereafter during treatment. Pre-defined questionnaire thresholds were used to identify clinically meaningful changes. Enrollment for PROSPER is complete and follow-up continues. This trial is registered with ClinicalTrials.gov (NCT02003924). Findings Patients were enrolled from 26 November 2013 to 28 June 2017. Median followup time for all patients was 18•5 months (interquartile range [IQR] 10•7-29•2 months) in the enzalutamide group and 15•1 months (IQR 7•4-25•9 months) in the placebo group. Patients randomised to receive enzalutamide or placebo had similar baseline PRO scores. Changes in 6 Further analyses are needed to determine potential associations between pain, HRQoL, and disease progression in non-metastatic castration-resistant prostate cancer. Implications of all the available evidence As patients with non-metastatic castration-resistant prostate cancer generally have low levels of pre-treatment pain and favourable HRQoL compared to patients with advanced disease, treatments should aim to improve clinical outcomes while maintaining pain control and HRQoL. The demonstrated efficacy, tolerability, and HRQoL profile suggest that enzalutamide represents a treatment option for patients with non-metastatic castrationresistant prostate cancer. PROSPER patient recruitment sites, principal investigators and patients recruited by site* Country Site # Study centre Principal investigator # patients randomised Denmark 421 Herlev Hospital Per Rathenborg

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