Prostate cancer in Asia: design of a patient registry to inform real-world treatments, outcomes, and quality of life
TL;DR: A prospective disease registry of PC patients presenting to participating tertiary-care hospitals in eight Asian countries will provide comprehensive and wide-ranging real-world information on how PC is diagnosed and treated in Asia, used to inform policy development for best practice and direct clinical study design evaluating new treatments.
Abstract: Background The incidence of prostate cancer (PC) in Asian countries is increasing for reasons that are not clear. Data describing how PC is diagnosed and treated are fragmented across Asia, with marked intercountry and intracountry differences in outcome and knowledge gaps in clinical diagnostic and treatment practices. To address these knowledge gaps, we have established a PC disease registry with the aim of providing a comprehensive picture of PC diagnosis, prognosis, treatment and outcome, population characteristics, and comorbidities in real-world clinical practice in Asia. Methods This is a multinational, multicenter, longitudinal, and observational registry of PC patients presenting to participating tertiary-care hospitals in eight Asian countries ( www.clinicaltrials.gov NCT02546908. Registry Identifier: NOPRODPCR4001). Approximately 3500-4000 eligible patients with existing or newly diagnosed high-risk localized PC (cohort 1), nonmetastatic biochemically recurrent PC (cohort 2), or metastatic PC (cohort 3) will be consecutively enrolled and followed-up for 5 years. An enrollment cap of 600 patients each will be applied to cohorts 1 and 2. Disease status is collected at enrollment, and outcome variables captured at 3-monthly intervals include diagnostic/staging, treatments including reason for change, laboratory results, comorbidities, and concomitant medications. Treatments and survival outcomes will be captured real time until study end. Patient-reported quality-of-life will be measured every 6 months, and medical resource utilization summarized at study end. Data analysis will include exploratory analyses of potential associations between multiple risk factors and socioeconomic variables with disease progression and evaluation of various treatments for PC including novel therapies on clinical outcome and health-related quality-of-life outcomes. Results 3636 men with PC were enrolled until July 2018; 416 in cohort 1, 399 in cohort 2 and 2821 in cohort 3. Discussion A total of 3636 patients were enrolled until July 2018. The prospective disease registry will provide comprehensive and wide-ranging real-world information on how PC is diagnosed and treated in Asia. Such information can be used to inform policy development for best practice and direct clinical study design evaluating new treatments.
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Fudan University1, University Health System2, Chiang Mai University3, National Taiwan University4, University of Malaya5, Sichuan University6, Yonsei University7, Hospital Kuala Lumpur8, Hirosaki University9, University of Ulsan10, Mahidol University11, National Cheng Kung University12, Janssen Pharmaceutica13
TL;DR: To document the management of advanced prostate cancer including diagnosis, prognosis, treatment, and care, in real‐world practice in Asia using the United in Fight against prOstate cancer (UFO) registry.
Abstract: OBJECTIVES To document the management of advanced prostate cancer including diagnosis, prognosis, treatment, and care, in real-world practice in Asia using the United in Fight against prOstate cancer (UFO) registry. PATIENTS AND METHODS We established a multi-national, longitudinal, observational registry of patients with prostate cancer presenting to participating tertiary care hospitals in eight Asian countries. A total of 3636 eligible patients with existing or newly diagnosed high-risk localised prostate cancer (HRL), non-metastatic biochemically recurrent prostate cancer (M0), or metastatic prostate cancer (M1), were consecutively enrolled and are being followed-up for 5 years. Patient history, demographic and disease characteristics, treatment and treatment decisions, were collected at first prostate cancer diagnosis and at enrolment. Patient-reported quality of life was prospectively assessed using the European Quality of Life-five Dimensions, five Levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy for Prostate Cancer questionnaires. In the present study, we report the first interim analysis of 2063 patients enrolled from study start (15 September 2015) until 18 May 2017. RESULTS Of the 2063 enrolled patients, 357 (17%), 378 (19%), and 1328 (64%) had HRL, M0 or M1 prostate cancer, respectively. The mean age at first diagnosis was similar in each group, 56% of all patients had extracapsular extension of their tumour, 28% had regional lymph node metastasis, and 53% had distant metastases. At enrolment, 62% of patients had at least one co-morbidity (mainly cardiovascular disease or diabetes), 91.8% of M1 patients had an Eastern Cooperative Oncology Group performance score of <2 and the mean EQ-5D-5L visual analogue score was 74.6-79.6 across cohorts. Treatment of M1 patients was primarily with combined androgen blockade (58%) or androgen-deprivation therapy (either orchidectomy or luteinising hormone-releasing hormone analogues) (32%). Decisions to start therapy were mainly driven by treatment guidelines and disease progression. Decision to discontinue therapy was most often due to disease progression (hormonal drug therapy) or completion of therapy (chemotherapy). CONCLUSION In the UFO registry of advanced prostate cancer in Asia, regional differences exist in prostate cancer treatment patterns that will be explored more deeply during the follow-up period; prospective follow-up is ongoing. The UFO registry will provide valuable descriptive data on current disease characteristics and treatment landscape amongst patients with prostate cancer in Asia.
9 citations
TL;DR: In this article, the authors describe the recent trend of ADT in newly-diagnosed prostate cancer for Asia focusing on Japan (high income country) and Malaysia (middle income country), based on the Asian Prostate Cancer (A-CaP) Study.
Abstract: The number of newly-diagnosed prostate cancer cases varies across Asia with higher mortality-to-incidence ratio reported in developing nations. Androgen deprivation therapy (ADT), alone or in combination, remains the mainstay of first-line treatment for advanced prostate cancer. Key findings of extensive research and randomised-controlled trials have shaped the current clinical practice and influenced clinical guidelines recommendations. We describe here the recent trend of ADT in newly-diagnosed prostate cancer for Asia focusing on Japan (high income country) and Malaysia (middle income country) based on the Asian Prostate Cancer (A-CaP) Study. Combination of radiotherapy and ADT or ADT alone was common in patients with intermediate-to-high risk localised and locally advanced disease. For metastatic prostate cancer, maximum androgen blockade (gonadotrophin-releasing-hormone [GnRH] agonist / antagonist plus anti-androgen) was prevalent amongst the Japanese patients whilst primary ADT alone with GnRH agonist / antagonist was widely practiced in the Malaysian cohort. Upfront combined therapy (ADT plus docetaxel or androgen receptor pathway inhibitor) has significantly improved the outcomes of patients with metastatic castration naive prostate cancer. Its application, however, remain low in our cohorts owing to patient's financial capacity and national health insurance coverage. Early detection remains the cornerstone in prostate cancer control to improve treatment outcome and patients' survival.
6 citations
01 Mar 2022
TL;DR: In this paper , a review article summarizes key findings and discusses the results of several studies investigating the association of androgen deprivation therapy with cognitive dysfunction and risk of dementia from various perspectives.
Abstract: The expansion of the indication to use androgen deprivation therapy (ADT) to treat patients with advanced or metastatic prostate cancer has dramatically increased over the recent decades, resulting in the progress of patients’ survival. However, chronic health implications can become more apparent as the number of long-term cancer survivors is expected to be increased along with the adverse effect of ADT. In particular, interest in investigating ADT, especially luteinizing hormone-releasing hormone (LHRH) agonist association with cognitive dysfunction has been growing. Previous studies in animals and humans suggest that the level of androgen decreases with age and that cognitive decline occurs with decreases in androgen. Correspondingly, some of the extensive studies using common neurocognitive tests have shown that LHRH agonists may affect specific domains of cognitive function (e.g., visuospatial abilities and executive function). However, the results from these studies have not consistently demonstrated the association because of its intrinsic limitations. Large-scale studies based on electronic databases have also failed to show consistent results to make decisive conclusions because of its heterogeneity, complexity of covariates, and possible risk of biases. Thus, this review article summarizes key findings and discusses the results of several studies investigating the ADT association with cognitive dysfunction and risk of dementia from various perspectives.
2 citations
TL;DR: It is clear that patients have recollections of a variety of negative experiences regarding the words/attitudes of their doctors at the time they received their prostate cancer diagnosis, and the use of narrative data would facilitate the appropriate application of commonly used guidelines for the delivery of cancer diagnoses tailored to individual patients in clinical practice.
Abstract: Objectives To explore the negative recollections of prostate cancer patients regarding the attitudes and language used by the doctors in delivering their diagnoses in Japan, in order to improve patient-centred communication. Design and setting This is a qualitative secondary analysis of the prostate cancer narrative data from the Database of Individual Patients’ Experiences-Japan archives. A thematic analysis was conducted regarding negative recollections of doctors’ words/attitudes when delivering a cancer diagnosis. Recruitment was based on maximum variation sampling. Participants were recruited from medical institutions, patient associations and through media advertisements. Participants Men with a diagnosis of prostate cancer (n=51). Findings Of the 51 participants, 17 had negative recollections of the doctors’ words/attitudes during the delivery of the cancer diagnosis. After thematic analysis, 11 categories emerged: ‘Surprised by the abrupt disclosure of the diagnosis’, ‘Displeased by the direct disclosure of the diagnosis to the patient in the absence of family members’, ‘Unable to accept the doctor’s negative words in the explanations’, ‘Unable to understand the doctor’s technical jargon’, ‘Distrust due to failure in diagnosis based on previous examinations’, ‘Aggrieved at the doctor’s unwillingness to allow questions’, ‘Dissatisfied with explanations involving facts only’, ‘Indignant over the unexpected disclosure of life expectancy’, ‘Unable to accept the doctor’s blame for the delay in the initial hospital visit’, ‘Uncomfortable with the usage of inappropriate metaphors’ and ‘Pessimistic thoughts despite optimistic explanations’. Conclusions It is clear that patients have recollections of a variety of negative experiences regarding the words/attitudes of their doctors at the time they received their prostate cancer diagnosis. Thus, the use of narrative data would facilitate the appropriate application of commonly used guidelines for the delivery of cancer diagnoses tailored to individual patients in clinical practice.
2 citations
TL;DR: A review article summarizes key findings and discusses the results of several studies investigating the ADT association with cognitive dysfunction and risk of dementia from various perspectives.
Abstract: The expansion of the indication to use androgen deprivation therapy (ADT) to treat patients with advanced or metastatic prostate cancer has dramatically increased over the recent decades, resulting in the progress of patients’ survival. However, chronic health implications can become more apparent as the number of long-term cancer survivors is expected to be increased along with the adverse effect of ADT. In particular, interest in investigating ADT, especially luteinizing hormone-releasing hormone (LHRH) agonist association with cognitive dysfunction has been growing. Previous studies in animals and humans suggest that the level of androgen decreases with age and that cognitive decline occurs with decreases in androgen. Correspondingly, some of the extensive studies using common neurocognitive tests have shown that LHRH agonists may affect specific domains of cognitive function (e.g., visuospatial abilities and executive function). However, the results from these studies have not consistently demonstrated the association because of its intrinsic limitations. Large-scale studies based on electronic databases have also failed to show consistent results to make decisive conclusions because of its heterogeneity, complexity of covariates, and possible risk of biases. Thus, this review article summarizes key findings and discusses the results of several studies investigating the ADT association with cognitive dysfunction and risk of dementia from various perspectives.
2 citations
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12,135 citations
TL;DR: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plusprednisone.
Abstract: As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P = 0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel. conclusions When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone.
5,264 citations
TL;DR: The panel recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up."
Abstract: In 1996 the American Society for Therapeutic Radiology and Oncology (ASTRO) sponsored a Consensus Conference to establish a definition of biochemical failure after external beam radiotherapy (EBRT). The ASTRO definition defined prostate specific antigen (PSA) failure as occurring after three consecutive PSA rises after a nadir with the date of failure as the point halfway between the nadir date and the first rise or any rise great enough to provoke initiation of therapy. This definition was not linked to clinical progression or survival; it performed poorly in patients undergoing hormonal therapy (HT), and backdating biased the Kaplan-Meier estimates of event-free survival. A second Consensus Conference was sponsored by ASTRO and the Radiation Therapy Oncology Group in Phoenix, Arizona, on January 21, 2005, to revise the ASTRO definition. The panel recommended: (1) a rise by 2 ng/mL or more above the nadir PSA be considered the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure be determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up." To avoid the artifacts resulting from short follow-up, the reported date of control should be listed as 2 years short of the median follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition would allow comparisons with a large existing body of literature.
2,331 citations
TL;DR: New consensus criteria for eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone are defined, with increasing emphasis on time-to-event end points as decision aids in proceeding from phase II to phase III trials.
Abstract: Purpose To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. Methods A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data.
2,012 citations
University of California, San Francisco1, Harvard University2, University of Paris-Sud3, Université de Montréal4, Radboud University Nijmegen5, Charité6, University of Texas MD Anderson Cancer Center7, Hebron University8, University of Colorado Denver9, Fred Hutchinson Cancer Research Center10, University of Western Sydney11, Institute of Cancer Research12, Janssen Pharmaceutica13, Memorial Sloan Kettering Cancer Center14
TL;DR: Treatment with abiraterone acetate prolonged overall survival compared with prednisone alone by a margin that was both clinically and statistically significant, and further support the favourable safety profile of abiraton acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer.
Abstract: Summary Background Abiraterone acetate plus prednisone significantly improved radiographic progression-free survival compared with placebo plus prednisone in men with chemotherapy-naive castration-resistant prostate cancer at the interim analyses of the COU-AA-302 trial. Here, we present the prespecified final analysis of the trial, assessing the effect of abiraterone acetate plus prednisone on overall survival, time to opiate use, and use of other subsequent therapies. Methods In this placebo-controlled, double-blind, randomised phase 3 study, 1088 asymptomatic or mildly symptomatic patients with chemotherapy-naive prostate cancer stratified by Eastern Cooperative Oncology performance status (0 vs 1) were randomly assigned with a permuted block allocation scheme via a web response system in a 1:1 ratio to receive either abiraterone acetate (1000 mg once daily) plus prednisone (5 mg twice daily; abiraterone acetate group) or placebo plus prednisone (placebo group). Coprimary endpoints were radiographic progression-free survival and overall survival analysed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, number NCT00887198. Findings At a median follow-up of 49·2 months (IQR 47·0–51·8), 741 (96%) of the prespecified 773 death events for the final analysis had been observed: 354 (65%) of 546 patients in the abiraterone acetate group and 387 (71%) of 542 in the placebo group. 238 (44%) patients initially receiving prednisone alone subsequently received abiraterone acetate plus prednisone as crossover per protocol (93 patients) or as subsequent therapy (145 patients). Overall, 365 (67%) patients in the abiraterone acetate group and 435 (80%) in the placebo group received subsequent treatment with one or more approved agents. Median overall survival was significantly longer in the abiraterone acetate group than in the placebo group (34·7 months [95% CI 32·7–36·8] vs 30·3 months [28·7–33·3]; hazard ratio 0·81 [95% CI 0·70–0·93]; p=0·0033). The most common grade 3–4 adverse events of special interest were cardiac disorders (41 [8%] of 542 patients in the abiraterone acetate group vs 20 [4%] of 540 patients in the placebo group), increased alanine aminotransferase (32 [6%] vs four [ vs 17 [3%]). Interpretation In this randomised phase 3 trial with a median follow-up of more than 4 years, treatment with abiraterone acetate prolonged overall survival compared with prednisone alone by a margin that was both clinically and statistically significant. These results further support the favourable safety profile of abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer. Funding Janssen Research & Development.
1,041 citations