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be offered as an alternative to conventional fractionation. The task force strongly encourages that these patients be treated as part of a clinical trial or multi-institutional registry. Comment: There is additional RCT evidence to support the recommendation of KQ3B that may increase the quality of evidence for the use of ultrahypofractionation in intermediate-risk disease from low to at least moderate . ENDORSED with comment KQ3C: In men with high-risk prostatecancer receiving EBRT, the task force (...) with the recommendations for information purposes. Guideline Endorsement 3-22 Section 2: Endorsement Methods Overview – April 28, 2020 Page 5 Selection of Guidelines The Radiation Treatment Program, Disease Pathway Management, Ontario GU Cancers Advisory Committee, GU disease site group (DSG) chairs reviewed the ASTRO, ASCO, and AUA evidence-based guideline on hypofractionated radiation therapy for localized prostatecancer and accepted it as potentially useful and relevant to guide practice in Ontario. Assessment
trial conducted at the US Department of Veterans Affairs and National Cancer Institute sites. The participants were men (n=731) ≤75yr of age with localized prostatecancer, prostate-specific antigen (PSA) <50ng/ml, life expectancy ≥10yr, and medically fit for surgery. Intervention: Radical prostatectomy versus observation. Outcome measurements and statistical analysis: All-cause mortality was assessed in the entire cohort and patient and tumor subgroups. Intention-to-treat analysis was conducted (...) with intermediate-risk disease although not in men with high-risk disease. Patient summary: In this randomized study, we evaluated death from any cause in men with early prostatecancer treated with either surgery or observation. Overall, surgery may provide small very long-term reductions in death from any cause and increases in years of life gained. Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease
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
Sequencing of Androgen-Deprivation Therapy With External-Beam Radiotherapy in Localized ProstateCancer: A Phase III Randomized Controlled Trial Dose-escalated radiotherapy (RT) with androgen-deprivation therapy (ADT) is a standard definitive treatment of localized prostatecancer (LPCa). The optimal sequencing of these therapies is unclear. Our phase III trial compared neoadjuvant versus concurrent initiation of ADT in combination with dose-escalated prostate RT (PRT).Patients with newly (...) diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen < 30 ng/mL were randomly allocated to neoadjuvant and concurrent ADT for 6 months starting 4 months before RT (neoadjuvant group) or concurrent and adjuvant ADT for 6 months starting simultaneously with RT (concurrent group). The primary end point was biochemical relapse-free survival (bRFS). Stratified log-rank test was used to compare bRFS and overall survival (OS). Incidence of grade ≥ 3 late RT-related
Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk ProstateCarcinoma: A Phase III Randomized Study The Veterans Affairs Cooperative Studies Program study #553 was designed to evaluate the efficacy of adjuvant chemotherapy added to the standard of care (SOC) for patients who are at high risk for relapse after prostatectomy.To test whether addition of chemotherapy to surgery for high-risk prostatecancer improves progression-free survival (PFS (...) ).Eligible patients after prostatectomy were randomized to the SOC group with observation or to the chemotherapy group with docetaxel and prednisone administered every 3 wk for six cycles. Randomization was stratified for prostate-specific antigen, Gleason, tumor stage, and surgical margin status.The primary endpoint was PFS. Secondary endpoints included overall, prostatecancer-specific, and metastasis-free survival, and time to androgen deprivation therapy.A total of 298 of the planned 636 patients
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
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
Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostatecancer: a multicentre, randomised, open-label, phase 2, crossover trial Abiraterone acetate plus prednisone and enzalutamide are both used for the treatment of metastatic castration-resistant prostatecancer. We aimed to determine the best sequence in which to use both drugs, as well as their second-line efficacy.In this multicentre, randomised, open-label, phase 2, crossover (...) trial done in six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant prostatecancer without neuroendocrine differentiation and Eastern Cooperative Oncology Group performance status 2 or less. Patients were randomly assigned (1:1) using a computer-generated random number table to receive either abiraterone acetate 1000 mg orally once daily plus prednisone 5 mg orally twice daily until PSA progression followed
, 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