title: Symptoms and Impacts in Non-Metastatic Castration-Resistant Prostate Cancer: Qualitative Study Findings.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Erin L
authors.initials: EL
authors.lastname: Tomaszewski
authors.affiliation: QuintilesIMS Inc., 3-5 rue Maurice Ravel, Levallois-Perret, 92594, Paris, France. Pierre.Moise@quintiles.com.
authors.forename: Pierre
authors.initials: P
authors.lastname: Moise
authors.affiliation: QuintilesIMS Inc., Cambridge, MA, USA.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Krupnick
authors.affiliation: QuintilesIMS Inc., Durham, NC, USA.
authors.forename: Jared
authors.initials: J
authors.lastname: Downing
authors.affiliation: QuintilesIMS Inc., Cambridge, MA, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Meyer
authors.affiliation: Astellas Medical Affairs, Global HEOR, Chertsey, UK.
authors.forename: Shevani
authors.initials: S
authors.lastname: Naidoo
authors.affiliation: Astellas Medical Affairs, Global HEOR, Leiden, The Netherlands.
authors.forename: Stefan
authors.initials: S
authors.lastname: Holmstrom
mesh_terms: D000726:Androgen Antagonists / Q000009:adverse effects; D006801:Humans; D007407:Interviews as Topic; D007989:Libido; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000071066:Patient Reported Outcome Measures; D064129:Prostatic Neoplasms, Castration-Resistant / Q000150:complications / Q000188:drug therapy / Q000473:pathology / Q000523:psychology*; D036301:Qualitative Research; D011788:Quality of Life / Q000523:psychology*; D012735:Sexual Dysfunction, Physiological / Q000209:etiology / Q000523:psychology*; D014555:Urination Disorders / Q000209:etiology / Q000523:psychology*
chemical_list: D000726:Androgen Antagonists
keywords: Androgen Deprivation Therapy; Enzalutamide; Erectile Dysfunction; Patient Interview; Sexual Dysfunction