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. 2017 Oct;10(5):567-578.
doi: 10.1007/s40271-017-0227-y.

Symptoms and Impacts in Non-Metastatic Castration-Resistant Prostate Cancer: Qualitative Study Findings

Erin L Tomaszewski  1 , Pierre Moise  2 , Robert N Krupnick  3 , Jared Downing  4 , Margaret Meyer  3 , Shevani Naidoo  5 , Stefan Holmstrom  6
Affiliations

Symptoms and Impacts in Non-Metastatic Castration-Resistant Prostate Cancer: Qualitative Study Findings

Erin L Tomaszewski et al. Patient. 2017 Oct.

Abstract

Objectives: We developed a conceptual model to define key concepts associated with patients' experiences with the signs, symptoms, and impacts of non-metastatic castration-resistant prostate cancer (M0-CRPC).

Methods: A targeted review of peer-reviewed literature, and other publicly available information, identified and categorized symptoms and impacts related to early-stage prostate cancer. Semi-structured interviews with five clinical experts helped determine the most relevant and important concepts for patients with M0-CRPC. Qualitative interviews with 17 patients with M0-CRPC identified the most frequently experienced symptoms and impacts, and their degree of interference with patients' lives. The findings from these three lines of evidence were summarized in a conceptual model.

Results: Literature searches identified mainly urinary, intestinal, and sexual symptoms. Experts noted the symptoms most frequently mentioned by patients include erectile dysfunction, loss of sexual desire or interest, incontinence/leaking, urgency, and hot flashes. Patient interviews confirmed the high frequency of erectile dysfunction, loss of libido, urinary urgency, and incontinence. The most frequently mentioned impacts expressed by patients were the need to monitor/plan for urinary frequency, interference with/restriction of daily activities, and frustration or anxiety over diagnosis, symptoms, or treatment. Symptoms and impacts most frequently experienced by patients were typically not those with the greatest effects on their lives; rather, those with the greatest consequences were related to treatment.

Conclusions: The leading concerns associated with M0-CRPC were related to voiding and sexual dysfunction. The most relevant symptoms and impacts expressed by patients may be a consequence of therapy rather than of the disease.

Keywords: Androgen Deprivation Therapy; Enzalutamide; Erectile Dysfunction; Patient Interview; Sexual Dysfunction.

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Conflict of interest statement

Funding

This study was funded by Astellas Pharma, Inc. and Medivation, Inc. (which was acquired by Pfizer, Inc. in September 2016), the co-developers of enzalutamide.

Conflict of interest

Pierre Moise, Robert N. Krupnick, Jared Downing, and Margaret Meyer are employees of QuintilesIMS, which received funding from Astellas to conduct the research/analyses reported. At the time this research was conducted and during the development of this publication, Erin L. Tomaszewski was an employee of QuintilesIMS. Shevani Naidoo and Stefan Holmstrom are employees of Astellas Pharma, Inc.

Figures

Fig. 1
Fig. 1
Screening and recruitment process for identifying and enrolling men with non-metastatic castration-resistant prostate cancer. GnRH gonadotropin-releasing hormone, LHRH luteinizing hormone-releasing hormone, PSA prostate-specific antigen
Fig. 2
Fig. 2
Preliminary conceptual model (literature)
Fig. 3
Fig. 3
Symptoms of a non-metastatic castration-resistant prostate cancer that were most frequently mentioned by patients during patient interviews and b castration-resistant prostate cancer that had the highest interference ratings as reported by patients. ED erectile dysfunction
Fig. 4
Fig. 4
a Most frequent impacts mentioned across categories and median interference score, as derived from patient interviews and b impact interference ratings reported by patients with non-metastatic castration-resistant prostate cancer
Fig. 5
Fig. 5
Conceptual model of the impact of non-metastatic castration-resistant prostate cancer elicited from patient interviews and quality-of-life measurement identified from the literature review. Concepts in bold text are the most salient concepts. Interference with daily activities is a specific impact that means restriction of physical exertion and constraints on performance on household management tasks. M0-CRPC non-metastatic castration-resistant prostate cancer, PSA prostate-specific antigen
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