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Found 20 results

  1. Abiraterone (Zytiga) is approved for supply on the Australian PBS under the following conditions: Authority Required Castration resistant metastatic carcinoma of the prostate Clinical criteria: • The treatment must be in combination with prednisone or prednisolone, AND • The treatment must not be used in combination with chemotherapy, AND • Patient must have failed treatment with docetaxel due to resistance or intolerance; OR • Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel, AND • Patient must have a WHO performance status of 2 or less, AND • Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone, AND • Patient must not have received prior treatment with enzalutamide; OR • Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal. (Current 7 June 2017. Check pbs.gov.au for the latest version.) So, for most men, only after treatment fails with the chemotherapy docetaxel. We can assume that the Australian supplier of abirateone (Janssen) will present the results of the latest STAMPEDE and LATITUDE trials to the government's expert committee (the PBAC) suggesting that abiraterone be made available to men on the PBS earlier in treatment. I am not a doctor, but these trial results are reported as being very strong. So it will come down to Janssen agreeing a pricing package with the government, if they can.
  2. Jim Marshall (not a doctor) said ... Earlier results When standard hormone therapy is no longer holding the cancer in check, adding abiraterone (always plus a steroid) delays progression of the cancer and extends life. These LATITUDE results Newly diagnosed metastatic men had: standard hormone therapy OR standard hormone therapy + abiraterone + a steroid The men who started abiraterone and hormone therapy at the same time took longer for their disease to progress, and survived longer. Standard hormone therapy Zoladex (Goserelin), Lupron (leuprorelin), Eligard (leuprolide), Lucrin (leuprorelin acetate), Suprefact/Suprecor (buserelin), Synarel (nafarelin), histrelin (Supprelin), Suprelorin/Ovuplant (deslorelin), Triptorelin (diphereline) and Firmagon (degarelix) ... end Jim N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1704174. [Epub ahead of print] Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. Fizazi K1, Tran N1, Fein L1, Matsubara N1, Rodriguez-Antolin A1, Alekseev BY1, Özgüroğlu M1, Ye D1, Feyerabend S1, Protheroe A1, De Porre P1, Kheoh T1, Park YC1, Todd MB1, Chi KN1; LATITUDE Investigators. Author information Abstract Background Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer. Methods In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival. Results After a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001). The median length of radiographic progression-free survival was 33.0 months in the abiraterone group and 14.8 months in the placebo group (hazard ratio for disease progression or death, 0.47; 95% CI, 0.39 to 0.55; P<0.001). Significantly better outcomes in all secondary end points were observed in the abiraterone group, including the time until pain progression, next subsequent therapy for prostate cancer, initiation of chemotherapy, and prostate-specific antigen progression (P<0.001 for all comparisons), along with next symptomatic skeletal events (P=0.009). These findings led to the unanimous recommendation by the independent data and safety monitoring committee that the trial be unblinded and crossover be allowed for patients in the placebo group to receive abiraterone. Rates of grade 3 hypertension and hypokalemia were higher in the abiraterone group. Conclusions The addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly increased overall survival and radiographic progression-free survival in men with newly diagnosed, metastatic, castration-sensitive prostate cancer. (Funded by Janssen Research and Development; LATITUDE ClinicalTrials.gov number, NCT01715285 .). PMID: 28578607 This extract can be found on http://PubMed.com, and is in the public domain. On PubMed.com there will be a link to the full paper (often USD$30+, sometimes free). Any highlighting (except the title) is not by the author, but by Jim Marshall. Jim is not a doctor.
  3. Jim Marshall (not a doctor) said ... Earlier STAMPEDE results An earlier version of the STAMPEDE trial looked at men newly diagnosed with metastatic prostate cancer. One group of men was given hormone therapy, then chemotherapy when that was not enough to control their cancer. The other group started with hormone therapy plus chemotherapy. Men survived 22 months longer if they started with hormone therapy + chemotherapy. These STAMPEDE results Mostly newly diagnosed men who needed hormone therapy had: standard hormone therapy OR standard hormone therapy + abiraterone + prednisolone (Abiraterone is always given with a steroid. Prednisolone is a steroid.) The men who started abiraterone and hormone therapy at the same time took longer for their disease to progress, and survived longer. Standard hormone therapy Zoladex (Goserelin), Lupron (leuprorelin), Eligard (leuprolide), Lucrin (leuprorelin acetate), Suprefact/Suprecor (buserelin), Synarel (nafarelin), histrelin (Supprelin), Suprelorin/Ovuplant (deslorelin), Triptorelin (diphereline) and Firmagon (degarelix) ... end Jim N Engl J Med. 2017 Jun 3. doi: 10.1056/NEJMoa1702900. [Epub ahead of print] Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. James ND1, de Bono JS1, Spears MR1, Clarke NW1, Mason MD1, Dearnaley DP1, Ritchie AWS1, Amos CL1, Gilson C1, Jones RJ1, Matheson D1, Millman R1, Attard G1, Chowdhury S1, Cross WR1, Gillessen S1, Parker CC1, Russell JM1, Berthold DR1, Brawley C1, Adab F1, Aung S1, Birtle AJ1, Bowen J1, Brock S1, Chakraborti P1, Ferguson C1, Gale J1, Gray E1, Hingorani M1, Hoskin PJ1, Lester JF1, Malik ZI1, McKinna F1, McPhail N1, Money-Kyrle J1, O'Sullivan J1, Parikh O1, Protheroe A1, Robinson A1, Srihari NN1, Thomas C1, Wagstaff J1, Wylie J1, Zarkar A1, Parmar MKB1, Sydes MR1; STAMPEDE Investigators. Author information Abstract Background Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. Methods We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). Results A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events). Conclusions Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476 , and Current Controlled Trials number, ISRCTN78818544 .). PMID: 28578639 This extract can be found on http://PubMed.com, and is in the public domain. On PubMed.com there will be a link to the full paper (often USD$30+, sometimes free). Any highlighting (except the title) is not by the author, but by Jim Marshall. Jim is not a doctor.
  4. Currently the Pharmaceutical Benefits Scheme provides that Abiraterone (Brand name Zytiga) must be taken with prednisone or prednisolone. At its March 2017 meeting the PBAC approved an application that whilst Abiraterone must be taken with a corticosteroid, the corticosteroid does not necessarily have to be prednisone or prednisolone. Patients and their doctors are now able to choose the corticosteroid that they use with Abiraterone. There has been evidence that corticosteroids other than prednisone or prednisolone may have less side effects or greater benefits.
  5. Chuck Maack's full information about Zytiga

    Zytiga info: I compiled this information for those patients who are being prescribed Zytiga/abiraterone acetate: Zytiga/abiraterone acetate or Xtandi/enzalutamide - What is the Difference?* http://tinyurl.com/9ozr5oa Something else to be aware: Zytiga Interactions: http://tinyurl.com/ln6elg7 It came to mind wondering how many patients and/or their caregivers prescribed Zytiga/abiraterone acetate have ever taken the important time to read all the details regarding the effects that may be experienced by patients and whether or not they and their prescribing physician are insuring that appropriate blood testing is being performed at appropriate intervals to be aware of the numerous effects that can occur in order to remedy those effects in short order or even realize, depending on blood level results, should stop continuing with this medication. Please take that important time to read the lengthy information in this paper: http://zytigahcp.com/prescribing-information . If there are areas you don’t understand but appear important, write notes and take them with you to your next doctor appointment. Zytiga is a remarkable medication for those who can tolerate the medication and whose blood levels remain within the defined appropriate levels. It provides at least a median of over 13 months effectiveness, and in my personal case has continued effectiveness for 36 months and continuing. The effectiveness of Zytiga can be noticed within a few weeks of starting this medication with PSA receding. But be aware that at some point if the PSA does a turn-around and start slowly elevating, do not stop the medication since this is an effect that occurs or some wherein for a couple months it look like Zytiga is failing, but then the PSA again resumes receding. That occurred to me after 5 months and I stopped the medication thinking it was failing. I learned from a Medical Oncologist who was involved in its early trials that this can happen, so about two months later I returned to Zytiga (accompanied by my continuing Lupron and Avodart) and my PSA has continued dropping with periodic staying at a same level for a couple months, then dropping, possibly slightly elevating, then stabilizing, then dropping – so some bounce-around but overall PSA staying low. Chuck
  6. ScienceDaily: Prostate Cancer News Taking a high-priced cancer drug with a low-fat meal can cut cost by 75% Posted: 13 Feb 2017 05:24 PM PST Taking one-fourth the standard dose of a widely used drug for prostate cancer with a low-fat breakfast can be as effective – and four times less expensive – as taking the standard dose as recommended: on an empty stomach. The finding has significant financial implications.
  7. Click here to read Malecare's report of a clinical trial which found that combining Xtandi and Zytiga and using them at the same time was NOT better then either of the drugs by themselves.
  8. Duration of Zytiga Response

    From Joel Novak at Malecare: "In a small (n=161 men) retrospectively study, the researchers examined patient characteristics, types and duration of prostate cancer therapies to see what parameters might effect the duration of Zytiga response. The researchers found that the lower the PSA at the time Zytiga was started, the longer primary ADT duration, no prior exposure to ketoconazole, no prior chemotherapy and longer chemotherapy duration were associated with a longer response to Zytiga. Simply stated, there was a correlation of a longer response in men who had a with smaller disease burden or less exposure to other prostate cancer therapies. The study was not heavily powered (only 161 men) and was retrospective so its conclusions, despite being very interesting, need to be considered with a grain of salt. However, you can still consider these findings when making treatment decisions." Reference: Predictors of duration of abiraterone acetate in men with castrate-resistant prostate cancer http://www.ncbi.nlm.nih.gov/pubmed/27502737
  9. Joel Nowak of Malecare reports on an abstract presented at the 2016 American Society of Clinical Oncology (ASCO) Scientific Meeting about how abiraterone (brand name Zytiga) and enzalutamide (brand name Xtandi) may cause cognitive impairment and mood changes. Interestingly the research showed that these side effects were more prevalent with enzalutamide than with abiraterone. Click on this link to read the Malecare report..
  10. Respected prostate cancer advocate, Joel Novak from Malecare, believes that Xtandi is superior to Zytiga. Click on this link to read his reasons why he thinks this. Do you agree?
  11. Cabazitaxel is a chemotherapy treatment which is used when patients become resistant to chemotherapy treatment with Docetaxel. Cabazitaxel improves overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Docetaxel. Androgen receptor splice variant 7 (AR-V7) in circulating tumuor cells (CTCs) from mCRPC patients was recently demonstrated to be associated with resistance to Abiraterone and Enzalutamide. A group of Dutch and Belgian researchers investigated whether this was also true for Cabazitaxel. They found that Cabazitaxel was effective even if AR-V7 was present. Reference "Efficacy of Cabazitaxel in Castration-resistant prostate cancer is independent of the presence of AR-V7 in Circulating Tumor Cells" Wendy Ostenk et al Article Information DOI: 10.1016/j.eururo.2015.07.007
  12. New Agents available overseas pre chemo

    In the United States men with prostate cancer can get access to Abiraterone (brand name Zytiga) and Enzalutamide (brand name Xtandi) before chemotherapy. We'd like to get to a stage in Australia where Abiraterone (brand name Zytiga) and Enzalutamide (brand name Xtandi) are available on the Pharmaceutical Benefits Scheme before chemotherapy. The Australian Pharmaceutical Benefits Advisory Committee, when considering applications to put drugs on the Pharmaceutical Benefits Scheme, looks at what its overseas equivalent bodies have done. Thanks to member Russ for letting us know that since 11 December 2015 Enzalutamide (but not Abiraterone) is now routinely available on the National Health Scheme in England and Wales, regardless of whether or not a man has previously been treated with docetaxel chemotherapy. In Scotland it's the reverse - Abiraterone (but not Enzalutamide) is now routinely available on the National Health Scheme in Scotland, regardless of whether or not a man has previously been treated with docetaxel chemotherapy. http://prostatecanceruk.org/about-us/news-and-views/2015/12/nice-decision-on-abiraterone-and-enzalutamide-without-chemotherapy
  13. New Clinical Trial of JNJ-56021927

    JNJ-56021927 (formerly known as ARN-509) is an androgen receptor antagonist. Some prostate cancer cells require androgens for growth. JNJ-56021927 prevent androgens from binding to the prostate cancer cells’ androgen receptors. JNJ-56021927 is not as advanced in its development as enzalutamide (Brand name Xtandi). Results from initial clinical trials suggest that JNJ-56021927 may be more potent and effective than enzalutamide. A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer is being conducted. Details of this trial can be found by clicking on this link: https://clinicaltrials.gov/ct2/show/NCT02257736 This clinical trial is being conducted at a number of hospitals in most Australian states. I am aware that the Royal Melbourne Hospital has commenced recruitment of patients for this trial. I'm not aware of the recruitment status of the other Australian sites but I expect that these sites will commence recruitment shortly, if they are not already doing so. There will be 2 arms of the trial. Patients on the 1st arm will receive Abiraterone, Prednisone and JNJ-56021927. Patients on the 2nd arm will receive Abiraterone, Prednisone and a placebo.
  14. I think it's important to pass on this information, particularly for those men whose ADT resulted in the prescribing of Zytiga/abiraterone acetate. I am working with a patient on ADT medications including Zytiga, also experiencing cardio issues, and recently edema. With ADT known to play a role in hypertension, cardio issues, diabetes, edema (swelling caused by excess fluid) , and other issues, among which this patient is experiencing, he was recently prescribed the medication Spironolactone by a cardiologist to help with his edema. Spironolactone turned out to have a very bad effect resulting in significant weight loss in just a few weeks. The patient and his caregiver did a check of this Spironolactone on the internet and found that this medication should definitely NOT be prescribed to patients being treated for prostate cancer with Zytiga. The patient immediately stopped the medication and will be notifying the cardiologist who prescribed the medication to make sure he is aware when any of his patients are also being treated for prostate cancer. Please take the time to read the information in this paper explaining: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3291010/ DISCLAIMER: Please recognize that I am not a Medical Doctor. I have been an avid student researching and studying prostate cancer as a survivor and continuing patient since 1992. I have dedicated my retirement years to continued research and study in order to serve as an advocate for prostate cancer awareness, and, from a activist patient’s viewpoint, to voluntarily help patients, caregivers, and others interested develop an understanding of prostate cancer, its treatment options, and the treatment of the side effects that often accompany treatment. There is absolutely no charge for my mentoring – I provide this free service as one who has been there and hoping to make your journey one with better understanding and knowledge than was available to me when I was diagnosed so many years ago. Readers of this paper must understand that the comments or recommendations I make are not intended to be the procedure to blindly follow; rather, they are to be reviewed as my opinion, then used for further personal research, study, and subsequent discussion with the medical professional/physician providing your prostate cancer care. Always as close as the other end of your computer to help address any prostate cancer concerns. Charles (Chuck) Maack - Prostate Cancer Patient/Activist/Mentor
  15. With increasing options to treat advanced prostate cancer, there is no clear agreement on the order in which these treatments should be given. I attach a chart prepared (following the STAMPEDE clinical trial which recommended early ADT and chemotherapy for certain patients) by an American oncologist setting out his view of what is currently best clinical practice in America. In Australia our options are more restricted: Abiraterone and Enzalutamide are only available on the Pharmaceutical Benefits Scheme after chemotherapy and Provenge is not available on the Pharmaceutical Benefits Scheme. Oldtimer's Disease - I can't remember which publication I found this table in. A prize for anyone who can tell me where it came from.
  16. http://tinyurl.com/pcwv6zd Information in the above reference indicates that the administration of Xofigo/Alpharadin/Radium 223 in company with abiraterone/Zytiga increased the effectiveness of Xofigo as well as overall survival. Combining EBRT (External Beam Radiation Therapy) with Xofigo increased likelihood of bone marrow failure.
  17. The American Prostate Cancer Foundation identified 8 highlights from this year's Annual Meeting of the American Society of Clinical Oncologists (ASCO).
  18. Taking Abiraterone (Zytiga) with Food

    For a while now there have been questions about whether taking abiraterone with food as opposed to without food could be clinically beneficial for patients. Some studies suggest that: It might be possible to reduce the side effects of abiraterone and prednisone by taking a lower dose of these drugs with food; and It might be possible to increase the benefit of a standard dose of abiraterone by taking the drug with food but there might be a risk of increased side effects in doing this. Taking abiraterone with food is contrary to the manufacturer’s instructions. You should not do this without consulting your doctor. For further reading on the subject from the “New” Prostate Cancer Infolink: Click here and here
  19. Thanks to Chuck Maack for drawing our attention to the report of a recent presentation by Dr Oliver A Sartor who was the principal North American investigator for the clinical trial that led to the approval by the United States Food and Drug Administration (FDA) for radium 223 (brand name Xofigo). In 2013 the FDA approved radium 223 for treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Dr Sartor said that determining whether or not a patient had symptoms of bone metastases could often be a grey area. He considered the extent of bone metastases was more important than the presence of pain in determining whether to treat a patient with radium 223. Dr Sartor was treating patients with metastatic castration-resistant prostate cancer who had a significant burden of bone-metastatic disease, even though they might not be considered symptomatic. After nearly a year of clinical use, Dr Sartor said that the optimal setting for radium 223 appeared to be in combination with new hormonal therapies such as Abiraterone (Xytiga) and Enzalutamide (Xtandi). At present a large multi-country Stage III clinical trial is about to start recruiting in Australia: Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms Dr Sartor said large clinical trials would be needed before radium 223 could be considered for use on patients who did not have metastatic disease or were not castration-resistant.
  20. Abiraterone Improves Survival in Metastatic Prostate Cancer Adapted from the NCI Cancer Bulletin. A multinational phase III trial found that the drug abiraterone acetate prolonged the median survival time of patients with metastatic castration-resistant prostate cancer by 4 months compared with patients who received a placebo. The preliminary results from the study were presented October 11, 2010, at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, and subsequently published in the New England Journal of Medicine on May 26, 2011. Standard prostate cancer treatments reduce blood levels of testosterone, the hormone that fuels the cancer’s growth. However, most prostate cancers eventually become resistant to these treatments. Such cancers are called castration-resistant prostate cancers. Abiraterone acetate is designed to treat these tumors by inhibiting the production of androgen in the testes, adrenal glands, and prostate cancer tumors themselves. The clinical trial included 1,195 patients from 13 countries whose metastatic prostate cancer had previously been treated with one of two chemotherapy regimens that included docetaxel. Among the 797 patients randomly assigned to receive abiraterone acetate plus the corticosteroid prednisone, median overall survival was 14.8 months. Among the 398 who received prednisone plus placebo, median survival was 10.9 months. Differences between the placebo and treatment groups also emerged for all of the trial’s secondary endpoints, including the time that it took for prostate-specific antigen (PSA) levels to increase, progression-free survival according to medical imaging, and the number of patients who experienced reductions in PSA levels after treatment. The benefits of abiraterone were determined during a prespecified interim analysis of the study results, prompting the trial’s Independent Data Monitoring Committee to recommend unblinding the trial and offering abiraterone acetate to patients in the placebo arm. “This is a major step forward in prostate cancer therapeutics,” said principal investigator Johann de Bono, M.D., Ph.D., of the Institute of Cancer Research and the Royal Marsden Hospital in the United Kingdom. “Men with metastatic…castration-resistant prostate cancer have a poor prognosis, with only about one in three alive 5 years after diagnosis,” he explained. “For many men, abiraterone acetate can extend life.” On the basis of these results, the Food and Drug Administration approved abiraterone in April 2011 for men with metastatic castration-resistant prostate cancer that has previously been treated with a chemotherapy regimen containing docetaxel. Abiraterone is the second drug approved for this type of advanced prostate cancer since June 2010. From the Web site of the National Cancer Institute (http://www.cancer.gov)
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