Metastatic castration resistant prostate cancer patients' experience with Radium-223 treatment in Japan.

Aim: We aimed to determine Japanese metastatic castration resistant prostate cancer (CRPC) patients' Ra-223 treatment experience. Patients & methods: Patients answered the Cancer Therapy Satisfaction Questionnaire (CTSQ domains: Satisfaction with Therapy [SWT], Expectations of Therapy [ET], Feelings about Side Effects [FSE]), the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) and the FACT-Bone Pain (FACT-BP) Questionnaire at baseline, during (vists 3 and 5) and after treatment (end of observation; EOO). Results: Data from 72 patients were included. Baseline median CTSQ scores SWT: 66.1 (IQR19.7), ET: 75.0 (IQR45), and FSE 68.8 (IQR 34.4) were unchanged during vists 3 and 5, but the SWT (-3.57 [IQR17.9]) and ET (-5.0 [IQR30]) decreased while FSE was unchanged (0.0 [IQR31.25]) at EOO. The median MAX-PC (18.0 [IQR 49]) score was unchanged (0.0, IQR 6) while the median FACT BP (54.0 [IQR13]) score decreased by -1.0 (IQR 8) at EOO. Conclusion: Japanese metastatic castration resistant prostate cancer patients' experience is stable during Ra-223 treatment.

What is this study about? We wanted to know the treatment experience with Radium-223 (Ra-223) among Japanese prostate cancer patients. Ra-223 is a radioactive molecule used for the treatment of metastatic castration resistant prostate cancer. We asked patients to answer different questionnaires on treatment satisfaction, anxiety and quality of life before, during, and after treatment with Ra-223. What were the results? Based on the patients' answers to our questionnaires, treatment satisfaction, anxiety and quality of life remain stable while the patients undergo treatment with Ra-223, but in some aspects may decline after treatment. What do the results mean? The results mean that patients' experience during Ra-223 treatment is stable but patients should share any concerns they have about their treatment with their doctors.

Conceptual assessment of HRQOL among Japanese non-metastatic castration-resistant prostate cancer (nmCRPC) patients.

OBJECTIVE: The study objectives were to understand how patients view the quality of life in non-metastatic castration-resistant prostate cancer (nmCRPC), including unmet needs and what patients consider most important in treatment outcomes. A gap analysis was conducted on existing patient-reported outcomes (PROs) measures versus what is missing from the patient perspective, to guide future development of PRO-based real-world evidence for nmCRPC in Japan. A conceptual model for nmCRPC Japanese patients' HRQOL was also created. METHODS: This non-interventional, qualitative study consisted of a targeted literature review, PRO instrument review, and interviews with 20 nmCRPC patients and five treating physicians. Triangulation of the gap analysis, evidence from the targeted review of the literature, and qualitative interview findings were employed to assess the comprehensiveness of current nmCRPC and HRQOL measures. RESULTS: Symptoms most reported by patients were frequent urination (70%), nocturia (65%), and general pain (65%). Others reported included lack of strength (30%). HRQOL impacts most reported were anxiety (45%) and worry (50%) about their diagnosis. Additional impacts mentioned were weight changes, loss of sleep, difficulty walking, loss of appetite, and difficulty traveling and seeking toilets in public. The gap analysis revealed 31 symptoms and 33 impacts not covered in existing prostate cancer-specific PRO instruments. Patients mentioned musculoskeletal symptoms such as fractures, leg pain, cramps, numbness, and loss of leg bone strength. Impacts not previously discussed in the literature or in outcome measures were feelings of self-consciousness around diagnosis, stigma around illness, and the impact on mobility including traveling. CONCLUSION: Key results reveal pain and urinary symptoms are the most experienced by Japanese nmCRPC patients. The diagnosis and treatment of disease leads to significant impacts in patient lives. Analysis revealed that symptoms and life impacts are missing in the current literature and outcome measures. Testing and debriefing of specific items could further substantiate these dimensions.

Unmet needs in non-metastatic castration-resistant prostate cancer from the Japanese patient perspective: a discrete choice experiment.

OBJECTIVES: With novel antiandrogen treatments of varying clinical benefits and risks becoming available, this study investigates how patients with castration-resistant prostate cancer (CRPC) value differences in treatment characteristics. DESIGN: Cross-sectional observational study. SETTING: A discrete choice experiment was conducted. Patients chose between two hypothetical non-metastatic CRPC (nmCRPC) treatments defined by six attributes: risk of fatigue, falls or fracture, cognitive impairment, hypertension, rashes as side effects to treatment and extension of time until cancer-related pain occurs. PARTICIPANTS: A total of 137 adult male patients with CRPC with no prior experience with chemotherapy and with Eastern Cooperative Oncology Group status 0-1 were recruited. Patients were excluded if they participated in an investigational programme outside of routine clinical practice, had a clinically relevant medical or psychiatric condition, or diagnosis of visceral/other metastases not related to the prostate, or were otherwise deemed ineligible by the referring physician. PRIMARY OUTCOME MEASURES: Relative preference weights and relative importance of the attributes was estimated by hierarchical Bayesian logistic regression. RESULTS: Among the treatment attributes, 'risk of cognitive impairment as a side effect of treatment' was the most important attribute (relative importance (RI) (95% CI): 27.47% (24.80% to 30.14%)), followed by 'extension of time until cancer-related pain occurs' (RI (95% CI): 17.87% (15.49% to 20.25%)) and the 'risk of falls or fracture' (RI (95% CI): 15.99% (14.73% to 17.25%)). The 'risk of hypertension as a side effect of treatment' (RI (95% CI): 13.77% (12.73% to 14.81%)) had similar RI as 'risk of rashes as a side effect of treatment' (RI (95% CI): 13.17% (12.15% to 14.19%)), followed by the 'risk of fatigue as a side effect of treatment' (RI (95% CI): 11.74% (10.75% to 12.73%)). CONCLUSIONS: Patients consider the risk of cognitive impairment as a side effect of treatment as the most important attribute in nmCRPC, followed by the extension of time until cancer-related pain occurs, and the risk of falls and fracture. These features should be considered in treatment decision making for nmCRPC in Japan.

Understanding Treatment Strategies and Preferences in Nonmetastatic Castration-Resistant Prostate Cancer From the Japanese Physician Perspective.

PURPOSE: Sixteen percent (16%) of patients with castration-resistant prostate cancer (CRPC) show no bone metastasis at diagnosis. However, 33% will become metastatic within 2 years. The goal of treatment in patients with nonmetastatic CRPC (nmCRPC), therefore, is to delay symptomatic metastases without undue toxicity. With novel antiandrogen treatments of different strengths and limitations available, physician preferences for nmCRPC treatment in Japan should be understood. METHODS: A discrete choice experiment was conducted. Physicians chose between two hypothetical treatments in nmCRPC defined by six attributes: risk of fatigue, falls or fracture, cognitive impairment, hypertension, rashes as side effects of treatment, and extension of time until cancer-related pain occurs. Relative preference weights and relative importance were estimated by hierarchical Bayesian logistic regression. Physicians were also asked to make treatment decisions based on four hypothetical patient profiles to understand the most important factors driving decision making. RESULTS: A total of 151 physicians completed the survey. Extension of time until cancer-related pain occurs was the most important attribute (relative importance, 32.3%; CI, 31.3% to 33.3%). Based on summed preference weights across all attributes, preferences for hypothetical treatment profiles I, II, and III were compared. A hypothetical treatment profile with better safety though shorter extension time was preferred (I: mean [standard deviation] = 1.7 [1.6 to 2.1]) over treatment profiles with lower safety but longer extension time (II: -2.7 [-2.8 to -2.6] and III: -0.2 [-0.3 to -0.1]). Treatment characteristics were more important factors for physicians' decision making than patient characteristics in prescribing treatment. CONCLUSION: Physicians preferred a treatment with better safety profile, and treatment characteristics were the most important factors for decision making. This might have implications in physicians' decision making for nmCRPC treatment in the future in Japan.

The treatment patterns of castration-resistant prostate cancer in Japan, including symptomatic skeletal events and associated treatment and healthcare resource use.

BACKGROUND: Real-world treatment patterns of bone metastatic castration-resistant prostate cancer (mCRPC) in Japan were examined, focusing on treatment patterns and resource use differences attributed to symptomatic skeletal events (SSEs). METHODS: Urologists (N = 176) provided retrospective chart data for patients with mCRPC (N = 445) via online surveys. Descriptive analyses and chi-square tests evaluated treatment patterns and their differences by SSE presence; generalized linear mixed models examined healthcare resource utilization differences as a function of SSEs. RESULTS: Patients were on average 73.6 years old (SD = 8.3), diagnosed with prostate cancer 5.1 years (SD = 6.2), castration-resistant 2.3 years (SD=2.0), and had 7.9 bone metastases sites (SD=12.4). Novel anti-hormones showed increased adoption as mCRPC treatment. Simultaneously, luteinizing hormone-releasing hormone (LHRH) agonist/antagonist use was common (43.6% of patients in 1st line), even as CRPC treatment had started. SSEs were uncommon (2-3% per treatment line; 5% at any time), but were associated with increased opioids, strontium-89, bisphosphonates, and NSAIDs use, plus increased healthcare visits (all p < .05). CONCLUSIONS: LHRH agonist/antagonist treatment combinations remain the mCRPC treatment mainstay in Japan. However, novel anti-hormone therapies are becoming well-accepted in practice. SSEs were associated with increased healthcare resource and analgesic use, highlighting the need for efficient symptom management.

Patient preferences for treatment of castration-resistant prostate cancer in Japan: a discrete-choice experiment.

BACKGROUND: Up to a fifth of patients diagnosed with prostate cancer (PC) will develop castration-resistant prostate cancer (CRPC), which has been associated with a poor prognosis. The aim of this study was to consider the patient perspective as part of the overall treatment decision-making process for CRPC, given that an alignment between patient preference and prescribing has been shown to benefit patient outcomes. This study examines preferences of patients with CRPC in Japan for treatment features associated with treatments like RA-223, abiraterone, and docetaxel and to examine the extent to which treatment preferences may vary between symptomatic and asymptomatic patients. METHODS: A two-phase research approach was implemented. In Phase 1, N = 8 patients with CRPC were recruited from a single hospital to complete a qualitative interview to provide feedback on the draft survey. In Phase 2, N = 134 patients with CRPC were recruited from five hospitals to complete a paper survey. The survey included 6 treatment choice questions, each asking patients to choose between two hypothetical treatments for their CRPC. Each treatment alternative was defined by the following attributes: length of overall survival (OS), time to a symptomatic skeletal event (SSE), method of administration, reduction in the risk of bone pain, treatment-associated risk of fatigue and lost work days. A hierarchical Bayesian logistic regression was used to estimate relative preference weights for each attribute level and mean relative importance. RESULTS: A total of N = 133 patients with CRPC completed the survey and were included in the final analysis. Patients had a mean age of 75.4 years (SD = 7.4) and had been diagnosed with PC a mean of 6.5 years prior (SD = 4.4). Over the attribute levels shown, fatigue (relative importance [RI] = 24.9 %, 95 % CI: 24.7 %, 25.1 %) was the most important attribute, followed by reduction in the risk of bone pain (RI = 23.2 %, 95 % CI: 23.0 %, 23.5 %), and OS (RI = 19.2 %, 95 % CI: 19.0 %, 19.4 %). Although symptomatic patients placed significantly more importance on delaying an SSE (p < .05), no other preference differences were observed. CONCLUSIONS: CRPC patients were more concerned about reduced quality of life from side effects of treatment rather than extension of survival, which may have implications for shared decision-making between patients and physicians.