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Enzalutamide with Standard First-Line Therapy in Metastatic ProstateCancer. Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostatecancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.In this open-label, randomized, phase 3 trial, we assigned patients to receive (...) ). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group.Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostatecancer receiving
Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostatecancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial In the interim analyses of the LATITUDE study, the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) led to a significant improvement in overall survival and radiographic progression-free survival compared with placebos plus ADT in men with newly (...) diagnosed high-risk metastatic castration-sensitive prostatecancer (mCSPC). Here, we present long-term survival outcomes and safety of abiraterone acetate plus prednisone and ADT from the final analysis of the LATITUDE study.This is a multicentre, randomised, double-blind, phase 3 trial done at 235 sites in 34 countries. Eligible patients (men aged ≥18 years) had newly diagnosed, histologically or cytologically confirmed prostatecancer with metastases, Eastern Cooperative Oncology Group (ECOG
with metastatic, castration-sensitive prostatecancer to receive apalutamide (240 mg per day) or placebo, added to ADT. Previous treatment for localized disease and previous docetaxel therapy were allowed. The primary end points were radiographic progression-free survival and overall survival.A total of 525 patients were assigned to receive apalutamide plus ADT and 527 to receive placebo plus ADT. The median age was 68 years. A total of 16.4% of the patients had undergone prostatectomy or received (...) Apalutamide for Metastatic, Castration-Sensitive ProstateCancer. Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostatecancer has not been determined.In this double-blind, phase 3 trial, we randomly assigned patients
that there are fewer people with undetected metastases who would otherwise be labelled as having non- metastatic disease. NICE technology appraisal guidance already recommends enzalutamide for hormone-relapsed metastatic prostatecancer before and after treatment with docetaxel. This appraisal relates to using enzalutamide at an earlier point in the treatment pathway. The committee noted that NHS England's policy stipulates that either enzalutamide or abiraterone (another antiandrogen) is to be offered only once (...) stopping treatment may speed up metastasis. The clinical experts commented that bicalutamide and dexamethasone are sometimes used for hormone-relapsed non-metastatic disease, but that the evidence for their effectiveness is limited. The committee considered ADT to be the standard of care in patients with hormone-relapsed prostatecancer, and the relevant comparator in this appraisal. The compan The company's definition of high risk does not closely match what is considered high y's definition of high
randomized NRG Oncology RTOG 0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009. Patients were randomly assigned to receive standard long-term AS plus RT with or without adjuvant CT.A total of 612 patients were enrolled; 563 were evaluable. Median prostate-specific antigen was 15.1 ng/mL; 53% had a Gleason score 9 to 10 cancer; 27% had cT3 to cT4 disease. Median follow-up was 5.7 years. Treatment was well tolerated in both arms. Four-year OS rate was 89% (95% CI, 84 (...) % to 92%) for AS + RT and 93% (95% CI, 90% to 96%) for AS + RT + CT (hazard ratio [HR], 0.69; 90% CI, 0.49 to 0.97; one-sided P = .034). There were 59 deaths in the AS + RT arm and 43 in the AS + RT + CT arm, with fewer deaths resulting from prostatecancer in the AS + RT + CT arm versus AS + RT (23 v 16 deaths, respectively). Six-year rate of distant metastasis was 14% for AS + RT and 9.1% for AS + RT + CT, (HR, 0.60; 95% CI, 0.37 to 0.99; two-sided P = .044). Six-year disease-free survival rate
Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant ProstateCancer PROSTVAC, a viral vector-based immunotherapy, prolonged median overall survival (OS) by 8.5 months versus placebo in metastatic castration-resistant prostatecancer in a phase II study. This phase III study further investigated those findings.Patients were randomly assigned to PROSTVAC (Arm V; n = 432), PROSTVAC plus granulocyte-macrophage colony-stimulating factor (Arm VG; n (...) for the treatment and placebo groups, with the most common being injection site reactions (62% to 72%) and fatigue (21% to 24%). Arrhythmias were the most common cardiac-related events (1.4% to 3.5%). There were no reports of either myocarditis or pericarditis. Serious treatment-related events occurred in less than 1% of all patients.Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostatecancer. Combination therapy is currently being explored
Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostatecancer. Multiparametric magnetic resonance imaging (MRI), with or without MRI-targeted biopsy, is an alternative test to systematic transrectal ultrasonography-guided biopsy in men suspected of having prostatecancer. At present, evidence on which test to use is insufficient to inform detailed evidence-based decision-making.To determine the diagnostic accuracy of the index tests MRI only, MRI (...) -targeted biopsy, the MRI pathway (MRI with or without MRI-targeted biopsy) and systematic biopsy as compared to template-guided biopsy as the reference standard in detecting clinically significant prostatecancer as the target condition, defined as International Society of Urological Pathology (ISUP) grade 2 or higher. Secondary target conditions were the detection of grade 1 and grade 3 or higher-grade prostatecancer, and a potential change in the number of biopsy procedures.We performed
Apalutamide (Erleada) - cancer of the prostate EMA/810516/2018 EMEA/H/C/004452 Erleada (apalutamide) An overview of Erleada and why it is authorised in the EU What is Erleada and what is it used for? Erleada is a cancer medicine used to treat men with cancer of the prostate (a gland of the male reproductive system). It is used when the cancer is not responding to treatments that lower testosterone levels and is at high risk of spreading to other parts of the body. Erleada contains the active (...) substance apalutamide. How is Erleada used? Erleada is available as tablets (60 mg) to be taken by mouth. The recommended dose is 4 tablets (240 mg) a day. Treatment may be stopped temporarily and later restarted at a reduced dose if the patient experiences intolerable side effects. Erleada can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of prostatecancer. For more information about using Erleada, see the package leaflet
Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostatecancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostatecancer. Here, we report the results of patient-reported outcomes of this study.In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done (...) at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostatecancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo. Randomisation was stratified by prostate-specific antigen doubling time and baseline use of a bone-targeting agent. The primary endpoint was metastasis-free survival, reported elsewhere
? Volker Vervölgyi ? Siw Waffenschmidt Keywords: abiraterone acetate, prednisone, prednisolone, androgen deprivation therapy, prostaticneoplasms, benefit assessment, NCT01715285, NCT00268476 Extract of dossier assessment A17-64 Version 1.0 Abiraterone acetate (prostatecancer) 13 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List of abbreviations v 2 Benefit assessment 1 2.1 Executive summary of the benefit assessment 1 2.2 (...) platform trial in advanced or metastatic prostatecancer on the comparison of different systemic drug therapies. The STAMPEDE study includes patients with prostatecancer for whom long-term ADT is intended and whose disease concurs with one of the following 3 groups: 1) newly diagnosed disease with presence of distant metastasis or lymph node metastasis, 2) newly diagnosed disease with high risk locally advanced prostatecancer without distant metastasis or lymph node metastasis, 3) recurrent locally
Abiraterone acetate (prostatecancer) - Addendum to Commission A17-64 1 Translation of addendum A18-26 Abirateronacetat (Prostatakarzinom) – Addendum zum Auftrag A17-64 (Version 1.0; Status: 11 May 2018). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 11 May 2018 1.0 Commission: A18-26 Version: Status: IQWiG Reports – Commission No. A18-26 Abiraterone (...) acetate (prostatecancer) – Addendum to Commission A17-64 1 Addendum A18-26 Version 1.0 Abiraterone acetate – Addendum to Commission A17-64 11 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Abiraterone acetate (prostatecancer) – Addendum to Commission A17-64 Commissioning agency: Federal Joint Committee Commission awarded on: 25 April 2018 Internal Commission No.: A18-26 Address
Use of Low-Dose Aspirin and Mortality After ProstateCancer Diagnosis: A Nationwide Cohort Study. Recent studies suggest that aspirin use may improve survival in patients with prostate cancer.To assess the association between postdiagnosis use of low-dose aspirin and prostatecancer mortality.Nationwide cohort study.Denmark.Men with incident prostateadenocarcinoma between 2000 and 2011.Nationwide registry data on tumor characteristics, drug use, primary prostatecancer therapy, comorbidity (...) , and socioeconomic parameters. Postdiagnosis use of low-dose aspirin (75 to 150 mg) was defined as 2 or more prescriptions filled within 1 year after prostatecancer diagnosis. Follow-up started 1 year after prostatecancer diagnosis. In secondary analyses, low-dose aspirin use was assessed within exposure periods of 5 or 7.5 years after prostatecancer diagnosis.Of 29 136 patients (median age, 70 years), 7633 died of prostatecancer and 5575 died of other causes during a median follow-up of 4.9 years
Health-related Quality of Life for Abiraterone Plus Prednisone Versus Enzalutamide in Patients with Metastatic Castration-resistant ProstateCancer: Results from a Phase II Randomized Trial Abiraterone and enzalutamide are associated with side effects that may impair health-related quality of life (HRQoL).To assess patient-reported HRQoL, depression symptoms, and cognitive function for abiraterone versus enzalutamide.We randomized 202 patients in a phase II study of abiraterone versus (...) enzalutamide for first-line treatment of metastatic castration-resistant prostatecancer (ClinicalTrials.gov: NCT02125357).Patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Patient Health Questionnaire-9 (PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments at baseline and on treatment.To compare the change in FACT-P scores over time between treatment arms, we used a mixed model for repeated measures (MMRM). For FACT-P domains where
were 18 years or older with locally advanced prostatecancer (either T2b-4, N0 M0 tumours or T2a, N0 M0 tumours provided Gleason score was ≥7 and baseline prostate-specific antigen [PSA] concentration was ≥10 μg/L). We randomly allocated participants in a 2 × 2 factorial design by computer-generated randomisation (using the minimisation technique, and stratified by centre, baseline PSA concentration, clinical tumour stage, Gleason score, and use of a brachytherapy boost) in a 1:1:1:1 ratio to four (...) Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostatecancer (TROG 03.04 RADAR): 10-year results from a randomised, phase 3, The optimal duration of androgen suppression for men with locally advanced prostatecancer receiving radiotherapy with curative intent is yet to be defined. Zoledronic acid is effective in preventing androgen suppression-induced bone loss
. prostaticneoplasms/ 2. (Prostat* adj4 (Neoplasm* or Cancer* or Carcinom* or Adenocarcinom* or Tumour* or Tumor* or Malignan* or Lump* or Masses* or Sarcom* or Metastas*)).tw. 3. 1 or 2 Spacer Inserts 4. Hydrogel/ 5. hydrogel*.tw. 6. hydrodissect*.tw. 7. (spacer* or spacing).tw. 8. ((perirect* or rect* or prostate-rectum or denonvillier* or transperineal*) adj4 space*).tw. 9. or/4-8 Limiting Terms 10. 3 and 9 12. 10 or 11 13. limit 12 to english language 14, limit 13 to human 15. limit 14 to yr=2017 (...) to the NICE document and the current review, the Cochrane review had a much broader remit and examined a large number of differing technologies, concentrating mainly on different RT techniques and doses in patients undergoing RT for pelvic malignancies. The MUHC technology assessment concluded that ?given the limited and inconclusive evidence of the clinical benefit of SpaceOAR®, and the high costs associated with its use at the MUHC routine use of SpaceOAR® in prostatecancer patients receiving RT
in UK practice and that 18 F-choline PET/CT is currently the only scan commissioned by NHS England in the national PET/CT tender. Axumin is designed to more effectively identify recurrent disease across a wide range of PSA levels compared with standard-of-care imaging (pelvic CT or MRI and bone scans). These lack the sensitivity and specificity to detect prostatecancer when PSA levels are low (Mottet et al. 2017; Cornford et al. 2017). The short uptake period for Axumin allows scans to be done 3 (...) of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 15Current care pathway NICE's guideline on prostatecancer: diagnosis and management recommends routine follow-up to identify recurrent disease in men who have had treatment for localised prostatecancer. According to the guideline, methods of monitoring disease control and detecting recurrence include physical examination, PSA blood tests and imaging investigations. It recommends that PSA levels are checked