Dataset Information

Appraising risk in active surveillance of localized prostate cancer.

ABSTRACT:

Objectives

Men diagnosed with low-risk prostate cancer are typically eligible for active surveillance of their cancer, involving monitoring for cancer progression and making judgements about the risks of prostate cancer against those of active intervention. Our study examined how risk for prostate cancer is perceived and experienced by patients undergoing active surveillance with their clinicians, how risk is communicated in clinical consultations, and the implications for treatment and care.

Method

Participants were nine patients and three clinicians from a university hospital urology clinic. A staged, qualitative, multi-method data collection approach was undertaken, comprising: observations of consultations; patient and clinician interviews; and patient surveys. The three data sets were analysed separately using thematic analysis and then integrated to give a comprehensive view of patient and clinician views.

Results

Thirty data points (eight patient surveys; 10 observations of consultations between patients and clinicians; 10 patient interviews; and two clinician interviews) combined to create a detailed picture of how patients perceived and appraised risk, in three themes of "Making sense of risk", "Talking about risk" and "Responding to risk".

Conclusion

Effective risk communication needs to be finely tuned and timed to individual patient's priorities and information requirements. A structured information exchange process that identifies patients' priorities, and details key moments in risk assessment, so that complexities of risk are discussed in ways that are meaningful to patients, may benefit patient care. These findings could inform the development of patient-centric risk assessment procedures and service delivery models in prostate cancer care more broadly.

SUBMITTER: Hogden A

PROVIDER: S-EPMC6803412 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Appraising risk in active surveillance of localized prostate cancer.

Hogden Anne A Churruca Kate K Rapport Frances F Gillatt David D

Health expectations : an international journal of public participation in health care and health policy 20190516 5

<h4>Objectives</h4>Men diagnosed with low-risk prostate cancer are typically eligible for active surveillance of their cancer, involving monitoring for cancer progression and making judgements about the risks of prostate cancer against those of active intervention. Our study examined how risk for prostate cancer is perceived and experienced by patients undergoing active surveillance with their clinicians, how risk is communicated in clinical consultations, and the implications for treatment and ...[more]

PMID: 31095822

Similar Datasets

Project description:ImportanceThere are few published studies prospectively assessing pharmacological interventions that may delay prostate cancer progression in patients undergoing active surveillance (AS).ObjectiveTo compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer.Design, setting, and participantsThe ENACT study was a phase 2, open-label, randomized clinical trial conducted from June 2016 to August 2020 at 66 US and Canadian sites. Eligible patients were 18 years or older, had received a diagnosis of histologically proven low-risk or intermediate-risk localized prostate cancer within 6 months of screening, and were undergoing AS. Patients were monitored during 1 year of treatment and up to 2 years of follow-up. Data analysis was conducted in February 2021.InterventionsRandomized 1:1 to enzalutamide, 160 mg, monotherapy for 1 year or continued AS, as stratified by cancer risk and follow-up biopsy type.Main outcomes and measuresThe primary end point was time to pathological or therapeutic prostate cancer progression (pathological, ≥1 increase in primary or secondary Gleason pattern or ≥15% increased cancer-positive cores; therapeutic, earliest occurrence of primary therapy for prostate cancer). Secondary end points included incidence of a negative biopsy result, percentage of cancer-positive cores, and incidence of a secondary rise in serum prostate-specific antigen (PSA) levels at 1 and 2 years, as well as time to PSA progression. Adverse events were monitored to assess safety.ResultsA total of 114 patients were randomized to treatment with enzalutamide plus AS and 113 to AS alone; baseline characteristics were similar between treatment arms (mean [SD] age, 66.1 [7.8] years; 1 Asian individual [0.4%], 21 Black or African American individuals [9.3%], 1 Hispanic individual [0.4%], and 204 White individuals [89.9%]). Enzalutamide significantly reduced the risk of prostate cancer progression by 46% vs AS (hazard ratio, 0.54; 95% CI, 0.33-0.89; P = .02). Compared with AS, odds of a negative biopsy result were 3.5 times higher; there was a significant reduction in the percentage of cancer-positive cores and the odds of a secondary rise in serum PSA levels at 1 year with treatment with enzalutamide; no significant difference was observed at 2 years. Treatment with enzalutamide also significantly delayed PSA progression by 6 months vs AS (hazard ratio, 0.71; 95% CI, 0.53-0.97; P = .03). The most commonly reported adverse events during enzalutamide treatment were fatigue (62 [55.4%]) and gynecomastia (41 [36.6%]). Three patients in the enzalutamide arm died; none were receiving the study drug at the time of death. No deaths were considered treatment-related.Conclusions and relevanceThe results of this randomized clinical trial suggest that enzalutamide monotherapy was well-tolerated and demonstrated a significant treatment response in patients with low-risk or intermediate-risk localized prostate cancer. Enzalutamide may provide an alternative treatment option for patients undergoing AS.Trial registrationClinicalTrials.gov Identifier: NCT02799745.

Dataset Information

Appraising risk in active surveillance of localized prostate cancer.

Objectives

Method

Results

Conclusion

Publications

Appraising risk in active surveillance of localized prostate cancer.

Similar Datasets

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