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MBS items to cover the urological component and radiation oncology component of LDR-BT for use as a boost to EBRT in patients with high- intermediate and high-risk prostatecancer. The proposed MBS item descriptors are summarised in Table 1. 4 Table 1 Applicant proposed MBS item descriptor Category 3 – Therapeutic procedures PROSTATE, radioactive seed implantation (radiation oncology component), using transrectal ultrasound guidance, for localised (non-metastatic) prostaticmalignancy classified (...) (urological component), using transrectal ultrasound guidance, for localised (non-metastatic) prostaticmalignancy classified as high-intermediate risk (defined as having a prostate specific antigen (PSA) of 10-20 ng/ml and a Gleason score of 7 and a tumour classified as T2b-c) or high risk (defined as having a PSA of greater than 20 ng/ml and/or a Gleason score of 8-10 and/or a tumour classified as T3). It is recommended the procedure only be performed as ‘boost’ treatment, in addition to external beam
prognostic models and enhanced prebiopsy imaging are mandatory. An essential consideration when implementing any tissue-based biomarker study in prostatecancer is that tissue-based molecular testing is dependent on the site of collection within the primary tumor and tumor content, and is significantly influenced by the heterogeneity of the disease. , , For the purpose of improving prognostic value, it is of paramount importance to select the areas that are characterized by the most aggressive disease (...) . were Expert Panel co-chairs. Abstract Section: PURPOSE This guideline provides recommendations for available tissue-based prostatecancer biomarkers geared toward patient selection for active surveillance, identification of clinically significant disease, choice of postprostatectomy adjuvant versus salvage radiotherapy, and to address emerging questions such as the relative value of tissue biomarkers compared with magnetic resonance imaging. METHODS An ASCO multidisciplinary Expert Panel
Apalutamide (Erleada) - non-metastatic castration-resistant prostatecancer (NM-CRPC) Published 10 February 2020 Statement of advice SMC2268 apalutamide 60mg film-coated tablets (Erleada®) Janssen-Cilag Ltd 10 January 2020 ADVICE: in the absence of a submission from the holder of the marketing authorisation apalutamide (Erleada®) is not recommended for use within NHSScotland. Indication under review: In adult men for the treatment of non-metastatic castration-resistant prostatecancer (NM-CRPC (...) ) who are at high risk of developing metastatic disease. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may be used without the whole of the advice being quoted in full. This advice represents the view of the Scottish Medicines Consortium and was arrived at after careful consideration and evaluation of the available evidence
with members from ASCO and the Society of Abdominal Radiology, American College of Radiology, Society of Nuclear Medicine and Molecular Imaging, American Urological Association, American Society for Radiation Oncology, and Society of Urologic Oncology to conduct a systematic review of the literature and develop an evidence-based guideline on the optimal use of imaging for advanced prostatecancer. Representative index cases of various prostatecancerdisease states are presented, including suspected high (...) based on the best available evidence. The fluid and rapidly evolving nature of the topic is acknowledged, and although regulatory approvals of some of the techniques presented are currently limited, this guideline is intended to preemptively address the ongoing barrage of studies that will most certainly transform the landscape for the management of patients with advanced prostatecancer. The term advanced prostatecancer encompasses a wide swath of patients with different disease states
for ProstateCancer guideline. This guideline included recommendations across a relatively broad clinical spectrum within prostatecancer. Topics addressed ranged from management of osteoporotic fracture risk in nonmetastatic disease to management of men with castration-resistant prostatecancer metastatic to bone. ASCO has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. METHODS The Bone Health and Bone-Targeted (...) -targeted therapies for prostatecancer. The CCO practice recommendations are drawn from data provided by randomized controlled trials (RCT) and systematic reviews of bone-targeted therapies in men with prostatecancer in a variety of settings. Relevant clinical risks range from osteoporotic fractures associated with androgen-deprivation therapy (ADT) to morbidity and death as a result of progression of bone-metastatic castration-resistant disease. In this document, the ASCO Expert Panel (Appendix
, and 230 deaths (49% of the subgroup). Median overall survival was not presented, HR=0.54 (95%CI: 0.41 to 0.70). The Kaplan Meier survival estimates at 36 months were 65% and 45% in the abiraterone and ADT groups respectively. 6, 7 A total of 283 patients (60%) had experienced disease progression, HR= 0.46 (95%CI: 0.36 to 0.59). 6 An opportunistic comparison of patients with high risk locally advanced or metastatic hormone-naïve prostatecancer who had been randomised to receive the abiraterone regimen (...) and responds to treatment that decreases androgen levels. 4 Prognostic factors for high risk disease include a PSA greater than 20ng/mL; having a tumour affecting both sides of the prostate gland and having a Gleason score of 8 to 10. Due to the nature of the disease, the majority of patients diagnosed with high risk mHSPC present with bone metastases, which increase the burden of disease and are a major cause of morbidity and mortality. 4 Treatment options include ADT with or without docetaxel (off-label
, Nieh PT, Yu W, Nye JA, Master V, et al. Initial experience with the radiotracer anti-1-amino-3- 18 F-fluorocyclobutane-1-carboxylic acid with PET/CT in prostatecarcinoma. J Nucl Med. 2007;48:56–63. 6. Evans JD, Jethwa KR, Ost P, Williams S, Kwon ED, Lowe VJ, et al. Prostatecancer-specific PET radiotracers: a review on the clinical utility in recurrent disease. PractRadiatOncol. 2018;8:28–39. 7. Okudaira H, Shikano N, Nishii R, Miyagi T, Yoshimoto M, Kobayashi M, et al. Putative transport (...) acid, a potential tumor-seeking agent. J Nucl Med. 1979;20:1055–61. 3. ShoupTM OJ, Hoffman JM, Votaw J, Eshima D, Eshima L, et al. Synthesis and evaluation of [ 18 F]1-amino-3-fluorocyclobutane-1-carboxylic acid to image brain tumors. J Nucl Med. 1999;40:331–8. 4. Oka S, Hattori R, Kurosaki F, Toyama M, Williams LA, Yu W, et al. A preliminary study of anti-1-amino-3- 18 F-fluorocyclobutyl-1-carboxylic acid for the detection of prostatecancer. J Nucl Med. 2007;48:46–55. 5. Schuster DM, Votaw JR
Montréal, Montreal, QC, Canada Cite as: Can Urol Assoc J 2019 December 5; Epub ahead of print. http://dx.doi.org/10.5489/cuaj.6384 Published online December 5, 2019 *** Introduction Metastatic prostatecancer remains an incurable disease. In Canada, approximately 8% of men with prostatecancer are diagnosed de novo with metastatic disease, and, in 2018, roughly 1200 men were diagnosed with de novo metastatic prostatecancer (PC) (1). The mainstay of treatment for de novo metastatic PC is androgen (...) deprivation therapy (ADT) which is initially effective in almost all patients. Progression is inevitable however, heralded by a rise in PSA, increasing disease burden and/or worsening symptoms, a disease state called metastatic castration resistant prostatecancer (mCRPC). Men with de novo metastatic PC have a poor prognosis with an estimated median overall survival of approximately 3-4 years (2). This has only improved slightly even in the advent of improved management of mCRPC (2, 3). Compared to PC
IQWiG employees involved in the dossier assessment: ? Sascha Abbas ? Christiane Balg ? Judith Gibbert ? Charlotte Guddat ? Michaela Florina Kerekes ? Inga Overesch ? Volker Vervölgyi ? Natalia Wolfram Keywords: apalutamide, prostaticneoplasms – castration-resistant, benefit assessment, NCT01946204 Extract of dossier assessment A19-09 Version 1.0 Apalutamide (prostatecancer)) 24 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv (...) as ? development of clinically significant symptoms due to locoregional tumour progression requiring surgical intervention or radiotherapy. A statistically significant difference between the treatment arms in favour of apalutamide + ADT in comparison with placebo + ADT was shown for the outcome “symptomatic Extract of dossier assessment A19-09 Version 1.0 Apalutamide (prostatecancer)) 24 April 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - progression”. This resulted in an indication
(HRQOL) in TITAN, including pain and fatigue.In this randomised, placebo-controlled, double-blind, phase 3 study, patients with metastatic castration-sensitive prostatecancer (defined as not receiving ADT at the time of metastatic disease progression) aged 18 years and older, receiving continuous ADT (selected at the investigator's discretion), and with an Eastern Cooperative Oncology Group performance status score of 0 or 1 were randomly assigned (1:1), using an interactive web response system (...) , to receive oral apalutamide (four 60 mg tablets, once daily) or matching placebo. Previous localised disease treatment or previous docetaxel for metastatic castration-sensitive prostatecancer were allowed. Randomisation was stratified by Gleason score at diagnosis, region, and previous docetaxel treatment. Randomisation was done using randomly permuted blocks (block size of four). Investigators, research staff, sponsor study team, and patients were masked to the identities of test and control treatments
Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostatecancers: a randomised, open-label, phase 1-2 trial Taxane-platinum combinations have shown promising activity in metastatic castration-resistant prostatecancers in single-group clinical studies but not in randomised trials. Distinct biological subsets of the disease might derive the greatest benefit from the addition of platinum. We aimed to determine whether adding carboplatin to cabazitaxel (...) would improve the outcomes of men with metastatic castration-resistant prostate cancer.We did a phase 1-2, open label, randomised study at two centres in men with progressive metastatic castration-resistant prostatecancer. In phase 1, patients received intravenous cabazitaxel 20-25 mg/m2 and intravenous carboplatin area under the curve (AUC) 3-4 mg/mL per min every 21 days. The maximum tolerated dose was defined as the highest dose cohort studied in which one of six or fewer patients experienced
Predicting ProstateCancer Death with Different Pretreatment Risk Stratification Tools: A Head-to-head Comparison in a Nationwide Cohort Study Numerous pretreatment risk classification tools are available for prostatecancer. Which tool is best in predicting prostatecancer death is unclear.To systematically compare the prognostic performance of the most commonly used pretreatment risk stratification tools for prostate cancer.A nationwide cohort study was conducted, including 154 811 men (...) in ProstateCancer data Base Sweden (PCBaSe) 4.0 diagnosed with nonmetastatic prostatecancer during 1998-2016 and followed through 2016.We compared the D'Amico, National Institute for Health and Care Excellence (NICE), European Association of Urology (EAU), Genito-Urinary Radiation Oncologists of Canada (GUROC), American Urological Association (AUA), National Comprehensive Cancer Network (NCCN), and Cambridge Prognostic Groups (CPG) risk group systems; the Cancer of the Prostate Risk Assessment (CAPRA
, the guideline attempts to provide expert opinion to aid in the management of patients. Levels of evidence and grades of recommendation employ the International Consultation on Urologic Disease (ICUD)/ WHO modified Oxford Center for Evidence-Based Medicine grading system. Based on a modified GRADE methodology, the strength of each recommendation is represented by the words STRONG or WEAK. Introduction Castration-resistant prostatecancer (CRPC) is defined by dis - ease progression despite castrate levels (...) of testosterone and may present as either a continuous rise in serum prostate- specific antigen (PSA) levels, the progression of pre-existing disease, and/or the appearance of new metastases. Advanced prostatecancer has been known under a few names over the years, including hormone-resistant prostate can - cer (HRPC) and androgen-insensitive prostatecancer (AIPC). Most recently, the terms castration-resistant prostatecancer or castration-recurrent prostatecancer were introduced with the realization
High Dose Rate Brachytherapy versus Low Dose Rate Brachytherapy for the Treatment of ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness High Dose Rate Brachytherapy versus Low Dose Rate Brachytherapy for the Treatment of ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness | CADTH.ca Find the information you need High Dose Rate Brachytherapy versus Low Dose Rate Brachytherapy for the Treatment of ProstateCancer: A Review of Clinical Effectiveness (...) and Cost-Effectiveness High Dose Rate Brachytherapy versus Low Dose Rate Brachytherapy for the Treatment of ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Last updated: February 14, 2019 Project Number: RC1070-000 Product Line: Research Type: Devices and Systems Report Type: Summary with Critical Appraisal Result type: Report Question What is the comparative clinical effectiveness of high-dose-rate versus low-dose-rate brachytherapy for the treatment of prostatecancer? What
Hydrogel Spacers for Patients with ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Hydrogel Spacers for Patients with ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness | CADTH.ca Find the information you need Hydrogel Spacers for Patients with ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Hydrogel Spacers for Patients with ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Last updated (...) : February 22, 2019 Project Number: RC1069-000 Product Line: Research Type: Devices and Systems Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of hydrogel spacers for patients with prostatecancer? What is the cost-effectiveness of hydrogel spacers for patients with prostatecancer? Key Message Three systematic reviews, one randomized controlled trial (described within two eligible reports), seven cohort studies, two economic evaluations
Androgen Receptor Targeted Agents for Castration Resistant ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Androgen Receptor Targeted Agents for Castration Resistant ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness | CADTH.ca Find the information you need Androgen Receptor Targeted Agents for Castration Resistant ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Androgen Receptor Targeted Agents for Castration (...) Resistant ProstateCancer: A Review of Clinical Effectiveness and Cost-Effectiveness Last updated: June 6, 2019 Project Number: RC1127-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the comparative clinical effectiveness of varying treatment sequences of androgen receptor targeted agents in patients with castrate-resistant prostatecancer? What is the comparative cost-effectiveness of varying treatment sequences of androgen
Darolutamide (TBD) for Non-Metastatic Castration Resistant ProstateCancer – Details Darolutamide (TBD) for Non-Metastatic Castration Resistant ProstateCancer – Details | CADTH.ca Find the information you need Darolutamide (TBD) for Non-Metastatic Castration Resistant ProstateCancer – Details Darolutamide (TBD) for Non-Metastatic Castration Resistant ProstateCancer – Details Project Number pCODR 10196 Brand Name TBD Generic Name Darolutamide Tumour Type Genitourinary Indication Non (...) -Metastatic Castration Resistant ProstateCancer Funding Request In combination with androgen depravation therapy (ADT), for the treatment of patients with non-metastatic castration resistant prostatecancer who are at high risk of developing metastases (high risk defined as prostate-specific antigen doubling time ≤ 10 months) during continuous ADT, and have a good Eastern Cooperative Oncology Group (ECOG) performance status Review Status Under Review Pre Noc Submission Yes NOC Date Manufacturer Bayer Inc