2015; 67 … Although abiraterone conferred unprecedented survival benefits and is better tolerated, not all oncologists agree it should replace docetaxel in the absence of a head-to-head comparative trial. Applications of radiation were in 55 Gy over 20 fractions or 36 Gy over 6 fractions. 9,10 These clinical trials improved … For men with nonmetastatic PC, February 2020 Journal of Clinical Oncology 38(6_suppl):14-14 7,8 Then, in 2017, two clinical trials, LATITUDE and STAMPEDE arm G, showed that up-front abiraterone plus prednisone plus ADT improves OS to a similar degree as docetaxel plus ADT did. One of the important and emerging questions in cancer metastasis is: how does the primary prostate tumor engage in cellular and molecular communication with potential locations for a metastasis, distant from the primary tumor, often in skeletal bone. Previous results from the STAMPEDE trial have shown that adding the chemotherapy drug docetaxel to standard hormone therapy improves how long men with prostate cancer live by about 10 months, compared to hormone therapy alone. Eur Urol. castrate-refractory prostate cancer), and docetaxel, with improved survival demonstrated in 2004. Quality-of-life scores have been analyzed in patients contemporaneously randomized to receive docetaxel or abiraterone in the STAMPEDE trial. Celestia S. Higano, MD. (UroToday.com) There have been significant changes in the landscape of treatment of metastatic hormone-sensitive prostate cancer (mHSPC) over the last five years, beginning with the publication of the CHAARTED trial and STAMPEDE Arm C demonstrating improved overall survival for patients receiving docetaxel in addition to androgen deprivation therapy. In 2015, the US-led CHAARTED trial ran-domised 790 mHSPC patients to ADT with or without 6 cycles of docetaxel [11]. Ann Oncol. Although STAMPEDE trial results presented at ASCO showed the survival benefit of abiraterone ... (ODM-201/BAY-1841788, Bayer) with ADT and docetaxel. In this trial, most men have standard hormone therapy as they usually would. Comparative quality of life in patients randomized contemporaneously to docetaxel or abiraterone in the STAMPEDE trial. 24 As per the STAMPEDE trial, upfront docetaxel improved the OS irrespective of the metastatic tumor burden … He goes on to discuss the advantages of both treatments and outlines when it might be best to use either … The LATITUDE and STAMPEDE trials — both supported by Janssen, the manufacturer of abiraterone — evaluated whether abiraterone would be more beneficial if used earlier. Barcelona, Spain (UroToday.com) Professor Nicholas James presented results from the STAMPEDE trial for the addition of docetaxel to first-line hormonal therapy for patients with metastatic (M1) hormone-naïve prostate cancer (mHNPC). ... long-term survival results from the STAMPEDE trial. STAMPEDE is a multi-arm, multistage trial that included both metastatic and non-metastatic prostate cancer patients . Comparative quality of life in patients randomized contemporaneously to docetaxel or abiraterone in the STAMPEDE trial. In addition to zoledronic acid and docetaxel, celecoxib, abiraterone, and enzalutamide are also being examined in STAMPEDE. San Francisco, CA (UroToday.com) Dr. Nicholas James presented results from the STAMPEDE trial for the addition of docetaxel to first-line hormonal therapy for patients with prostate cancer. Patients were randomised to receive either docetaxel plus standard hormone therapy, or abiraterone plus standard hormone therapy. The primary analysis of STAMPEDE’s ‘docetaxel comparison’, reporting an improvement in survival, was triggered by reaching a pre-specified number of control group deaths [].The trial team agreed to update this analysis when there was a meaningful increase in the number of primary outcome measure events after further follow-up, expected to occur ∼3 years later. 2019 Dec 1;30(12):1992-2003. doi: 10.1093/annonc/mdz396. The STAMPEDE trial allowed docetaxel in both arms in addition to ADT, and radiotherapy to the primary started within 3–4 weeks after docetaxel. 2019 Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial Annals of Oncology 2019 This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols Trials Results from the STAMPEDE trial, the largest randomized trial of treatment for prostate cancer, show that adding docetaxel, but not zolendronic acid, to long-term hormone therapy in treatment-naïve men with high-risk locally advanced or metastatic prostate cancer significantly improves survival. megsdad over 3 years ago. docetaxel(withorwithoutotheragents)[3–6].Resultsfrom some of the largest of these trials, including STAMPEDE [7], have now emerged and been combined in a meta-analysis [8]. Without this trial design, and the NCRI Prostate Group that helped to develop it, it would have taken significantly longer to test these treatments, and the trials would have been more expensive. Take-home messages. These results are congruent with emerging results from other trials in men starting long-term hormone therapy. The docetaxel results showed an improvement in overall survival (HR 0·78; 95% CI 0·66–0·93; p=0·006). In the whole population, radiotherapy improved failure-free survival (HR 0.76; 95% CI 0.68–0.84; p < 0.0001) but not OS (HR 0.92; 95% CI 0.80–1.06). Lancet. The trial investigates new approaches for men with metastatic and locally advanced prostate cancer. In the multi-arm STAMPEDE trial, 2,061 patients with newly diagnosed metastatic prostate cancer were randomized to either a standard treatment control group receiving ADT (an in some cases docetaxel), or to a The data from the STAMPEDE trial and from the earlier CHAARTED trial on the use of docetaxel + ADT apply exclusively to men who were ADT-naive at the time of initiation of therapy. ASCO GU 2020: STAMPEDE Trial - Comparative Quality of Life in Patients Randomized Contemporaneously to Docetaxel of Abiraterone San Francisco, California (Urotoday.com) The multi-arm, multi-stage STAMPEDE trial has been a pivotal study in cementing novel drug combinations in the standard of care of localized and advanced prostate cancer over the last 10 years, with over 11,000 … Epub 2014 Oct 6. The dataset for this analysis was frozen on 13 July 2018. Patients with high-risk prostate cancer beginning long-term androgen deprivation therapy (ADT) showed similar outcomes from the addition of abiraterone acetate plus prednisolone or docetaxel plus prednisone, according to findings from the STAMPEDE trial presented during ESMO 2017, the Annual Congress of the European Society for Medical Oncology in Madrid, Spain. STAMPEDE is an acronym for "Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy". STAMPEDE Trial Specifics Both groups were included in the STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) trial, which has now enrolled more than 9,000 men with advanced (non-metastatic and metastatic) prostate cancer since October 2005 and has looked at nearly a dozen different drugs to treat the disease. STAMPEDE, a multi-arm multi-stage platform trial, recruited patients (pts) to treatments including DOC or ABI between Nov-11 and Mar-13. Matthew Sydes talks with ecancer at the ESMO 2017 Congress about the STAMPEDE trial, assessing the use of abiraterone acetate plus prednisolone or abiraterone acetate plus docetaxel for patients with high-risk prostate cancer starting long-term androgen deprivation therapy.. To date, there has been roughly a 40% improvement in clini-cal progression free survival, biochemical free survival and median overall survival with addition of docetaxel. This is … Arm H of the STAMPEDE trial randomized men with mCSPC to standard care, defined as ADT or ADT plus docetaxel, or standard care plus radiation . Docetaxel reduced the risk of FFS by 39%, compared with 69% for abiraterone. Hello to the forum. This film explores the results of the STAMPEDE trial. ADT-docetaxel: 60.9 m ADT alone: 46.5 m p = 0.44 Gravis, et al. Survival with newly diagnosed metastatic prostate cancer in the “docetaxel era”: data from 917 patients in the control arm of the STAMPEDE trial (MRC PR08, CRUK/06/019). The differerent treatments include. However, whether abiraterone is better than docetaxel in this population remains a debate. STAMPEDE, a multi-arm multi-stage platform trial, recruited patients (pts) to treatments including DOC or ABI between Nov-11 and Mar-13. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial Ann Oncol. 2019 Dec 1;30(12):1992-2003.doi: 10.1093/annonc/mdz396. This is according to results from the STAMPEDE trial which were presented yesterday at the Genitourinary Cancers Symposium in San Francisco. The STAMPEDE trial uses a novel multigroup, multistage (also called multiarm, multistage ... docetaxel at the inception of ADT increased me-dian survival from 71 months to 81 months as Cancer) trial randomized 397 patients to ADT+docetaxel and compared them with 393 patients undergoing ADT alone [5]. Similar results were confirmed in arm C of the STAMPEDE (Sys- In this video, Dr. Nicholas David James discusses the results of the STAMPEDE trial, which tested front-line docetaxel combined with hormonal therapy in patients … Since opening in 2005 over 10 000 participants have joined the trial. The study by Nicholas James and colleagues (March 19, p 1163)1 shows that the addition of docetaxel to androgen deprivation therapy improved survival in patients with hormone-sensitive metastatic, high-risk, node-positive, or recurrent prostate cancer. In an exciting development, James et al. The STAMPEDE trial previously reported that the use of upfront docetaxel lead to an improvement in overall survival for patients with metastatic hormone-naïve prostate cancer starting long-term androgen deprivation therapy. STAMPEDE aims to provide evidence as to what is the best way of treating men with newly diagnosed advanced prostate cancer. Celecoxib, zoledronic acid, docetaxel and abiraterone alone have previously been tested. In findings from the STAMPEDE trial, a trial that has enrolled more than 9000 men with M0 and M1 prostate cancer since 2005, the addition of docetaxel (Taxotere) to frontline long-term hormone therapy improved quality of life and reduced the need for subsequent therapy in patients with advanced prostate cancer. Had radiotherapy 4 years ago and all seemed fine - until now. How Randomized Trials of STAMPEDE Have Influenced Treatment Decisions in the United Kingdom. Lancet Oncology 2015 12 Upfront Use of Chemo in Hormone Sensitive Metastatic Disease Failed Attempt 1 : GETUG 15 GETUG15 The first trial in HSPC testing Docetaxel A negative Trial The findings from this trial are now being translated into practice, with docetaxel now available on the NHS as an additional treatment for men with metastatic prostate cancer. BackgroundBoth Docetaxel (DOC) and Abiraterone (ABI) improve the survival of men with metastatic, castration sensitive prostate cancer (mCSPC). Hello to the forum. I have been offered the Stampede trial and would like to hear from anyone that has completed or in the process of being in the trial. Randomised controlled trials. In 2015 the STAMPEDE trial reported that men with metastatic prostate cancer (cancer that has spread to other parts of the body) who were taking docetaxel chemotherapy at the same time as hormone therapy lived for an average of 15 months longer than those taking hormone therapy alone. Because the STAMPEDE RCTs for docetaxel and abiraterone occurred at about the same time, 566 patients were randomized to one or the other. Three randomised controlled trials were included in this review for hormone-sensitive high risk prostate cancer. Results from the STAMPEDE trial, the largest randomized trial of treatment for prostate cancer, show that adding docetaxel, but not zolendronic acid, to long-term hormone therapy in treatment-naïve men with high-risk locally advanced or metastatic prostate cancer significantly improves survival. More importantly, there was a randomized clinical trial where newly diagnosed men entering the STAMPEDE trial were randomized to either docetaxel or abiraterone. However, the outcome among mCSPC patients is highly variable, while there is a lack of predictive markers of therapeutic benefit. 24 As per the STAMPEDE trial, upfront docetaxel improved the OS irrespective of the metastatic tumor burden … Abiraterone reduced PSA more quickly, as reflected in "failure-free survival" (time to PSA increase, clinical progression, or death) and "progression-free survival" (time to … ASCO 2017 - Prof Nicholas James Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): long-term survival, quality-adjusted survival and cost-effectiveness analysis. One of the important and emerging questions in cancer metastasis is: how does the primary prostate tumor engage in cellular and molecular communication with potential locations for a metastasis, distant from the primary tumor, often in skeletal bone. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. Epub 2015 Dec 21. III trials: CHAARTED, STAMPEDE and GETUG-AFU 15. Trial … Several other trials in addition to STAMPEDE have assessed both drugs in the newly diagnosed setting, most notably GETUG-15 and CHAARTED, which assessed docetaxel in the metastatic setting (about 60% of the population used in our trial). A bisphosphonate called zoledronic acid (zoledronate or Zometa) A chemotherapy drug called docetaxel (Taxotere) The overall conclusion was that "standard of care should be updated to include docetaxel chemotherapy in suitable patients with metastatic disease, and docetaxel may be considered for men with high-risk non-metastatic prostate cancer with or without radiotherapy". Parker, James & Brawley 2018 reported on radiotherapy. 117 hospitals in the UK and Switzerland are involved with over 10,000 men are expected to take part in the trial. 2018 May 1;29(5):1235-1248. doi: 10.1093/annonc/mdy072. Sydes et al. 2019 Dec 1;30(12):1992-2003. doi: 10.1093/annonc/mdz396. recently published data from the Systemic Therapy in Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: a multi-stage multi-arm randomised control trial (STAMPEDE). Furthermore, recent data from the phase III STAMPEDE trial corroborate the robust increment provided by combining docetaxel with ADT in patients with metastatic or high-risk non-metastatic castration-sensitive disease [4]. 33 Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. We also Celecoxib, zoledronic acid, docetaxel and abiraterone alone have previously been tested. 57.6 months with docetaxel with ADT vs 44.0 months with ADT alone (hazard ratio 0.49, 95% CI 0.37–0.65; P < 0.001). Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019) Eur Urol. STAMPEDE trial and patients with non-metastatic prostate cancer The study by Nicholas James and colleagues (March 19, p 1163)1 shows that the addition of docetaxel to androgen deprivation therapy improved survival in patients with hormone-sensitive metastatic, high-risk, node-positive, or recurrent acknowledge this limitation. In the docetaxel plus ADT arm of STAMPEDE, 77% of men received the planned 6 cycles of docetaxel and, in men who … The entire STAMPEDE trial includes 9 arms and approximately 7000 patients. Adding chemotherapy to hormone therapy improves survival of men with prostate cancer, according to results from the STAMPEDE trial presented at the American Society of … There are no data whatsoever (that I am aware of ) to suggest that using the combination of docetaxel + ADT in a man like you who has previously been treated with ADT would have any significant effect on your … As reported previously, baseline patient characteristics were well-balanced across trial arms . Findings from the CHAARTED, LATITUDE, and STAMPEDE trials 1-3 showed various results for adding docetaxel (Taxotere) or abiraterone acetate (Zytiga) to androgen deprivation therapy (ADT) in prostate cancer, and this kicked off a challenging issue for clinicians: Is it better to add docetaxel, abiraterone acetate, both, or neither to their patient’s treatment plan? Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial Lancet . All three unique studies were directly applicable as they matched the protocol. The trial team have published some results for the STAMPEDE trial. Upfront Docetaxel - STAMPEDE trial update. I have been offered the Stampede trial and would like to hear from anyone that has completed or in the process of being in the trial. Traditionally, docetaxel systemic chemotherapy was reserved for patients in the mCRPC space, but 3 trials analyzed in aggregate [] have confirmed its efficacy at improving survival when given with ADT for mCSPC.The CHAARTED (Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) trial randomized 397 patients to ADT+docetaxel and … STAMPEDE trial and patients with non-metastatic prostate cancer. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. This proportion decreases to 46% (203 of 441 men) in N+M0 patients. STAMPEDE looked at whether adding docetaxel or zoledronic acid, or a combination of both, to standard treatment… 2016 Mar 19;387(10024):1163-77.doi: 10.1016/S0140-6736(15)01037-5. Some will have other treatments as well, or will have a different treatment instead of hormone therapy. In summary, the main findings are: adding docetaxel to hormone therapy improves the length of … Active treatments have not been compared in head-to-head trials except for docetaxel and abiraterone acetate, which were compared in the only multiarm RCT: the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) trial. Regressions of metastatic prostate cancer were first documented in the 1940s and were achieved with surgical castration; subsequently, androgen-deprivation therapy (ADT) became the mainstay of therapy.1 Attempts to improve the efficacy or decrease the treatment burden of Take-home messages. 2015 Jun;67(6):1028-1038. doi: 10.1016/j.eururo.2014.09.032. The common methodology used throughout the STAMPEDE trial permits high-quality indirect comparison. ASCO … Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. To date, there are two randomized trials assessing the role of radiotherapy to the prostate in patients with metastatic prostate cancer. Had radiotherapy 4 years ago and all seemed fine - until now. Docetaxel (DOC) and abiraterone (ABI) both improve overall survival (OS) in men with locally advanced or metastatic hormone-sensitive prostate cancer (HSPC) but no head to head trials compare the 2 agents. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial Ann Oncol . medwireNews: Men with metastatic hormone-naïve prostate cancer (mHNPC) have improved outcomes with the addition of docetaxel to androgen deprivation therapy (ADT) irrespective of whether they have high or low burden of disease, indicates an analysis of the STAMPEDE trial.. Presenting the findings at the ESMO Congress 2019 in Barcelona, Spain, study author Nicholas … Since 2015, two clinical trials, CHAARTED and STAMPEDE arm C, demonstrated that up-front docetaxel plus ADT improves overall survival (OS) in patients with mCSPC. UCL Discovery is UCL's open access repository, showcasing and providing access to UCL research outputs from all UCL disciplines. ASCO 2017 - Prof Nicholas James STAMPEDE / LATITUDE coverage overview. Docetaxel Chemotherapy for Metastatic Hormone Sensitive Prostate Cancer A systematic review and meta-analyses of the aggregate data of the CHAARTED, GETUG-AFU15, and STAMPEDE trials indicated that the upfront use of docetaxel showed better OS in patients with mCSPC than in those with ADT alone (HR, 0.77; 95% CI, 0.68–0.87; p < 0.0001). Recently, the STAMPEDE trial directly compared ADT plus docetaxel and ADT plus abiraterone in men with mHSPC based on its multi-arm design and showed an advantage of ADT plus abiraterone on FFS but not OS compared to ADT plus docetaxel . Stampede Trial - Docetaxel Chemo. For docetaxel: In STAMPEDE, they gained 1.4 years; in CHAARTED they gained 1.1 years. One thousand and eighty-six metastatic patients (724 control/362 docetaxel) were recruited to STAMPEDE’s ‘docetaxel comparison’ between 05 October 2005 and 31 March 2013. The same meta-analysis examined 11 trials of docetaxel for men with M0 disease and included GETUG-12 , RTOG-0521 and STAMPEDE-M0 trials . Table 2: Docetaxel doses used in the studies Study Study arms Doses STAMPEDE James 2016 (United Kingdom) ADT (plus radiotherapy) versus ADT plus docetaxel Celecoxib, zoledronic acid, docetaxel and abiraterone alone have previously been tested. The key characteristics and results of these three trials are shown in Table 2. Several other trials in addition to STAMPEDE have assessed both drugs in the newly diagnosed setting, most notably GETUG-15 and CHAARTED, which assessed docetaxel in the metastatic setting (about 60% of the population used in our trial). Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol Ann Oncol . Background: Docetaxel (DOC) and abiraterone (ABI) both improve overall survival (OS) in men with locally advanced or metastatic hormone-sensitive prostate cancer (HSPC) but no head to head trials compare the 2 agents. reported the outcomes after a median of 4 years of follow-up. Collectively, these studies showed that six cycles of docetaxel extend survival and failure-free survival (FFS) for men with metastatic PC. Adding chemotherapy to hormone therapy improves survival of men with prostate cancer, according to results from the STAMPEDE trial presented at the American Society of …
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