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  1. Jim Marshall (not a doctor) said ... If you have castrate-resistant prostate cancer, common treatments that your doctor may add to your regular ADT treatment include: Docetaxel (Taxotere) Enzalutamide (Xtandi) or Abiraterone (Zytiga) Cabazitaxel (Jevtana). But what are your doctor's drug choices when the cancer is no longer under control after all three options? If you responded to docetaxel, your doctor knows you may well respond again to another dosing of docetaxel. But this increases your risk of side effects - especially peripheral neuropathy or nail disorders. Thibault and her colleagues looked at the possibility of giving cabazitaxel another go. They report a benefit to men - 34.3% improved, and 47.8% remained stable. Peripheral neuropathy: nerve damage to hands and feet. Castrate-resistant prostate cancer: PSA going up, even though testosterone is very low. ... end Jim The full article can be found in the European Journal of Cancer 2018: http://www.ejcancer.com/article/S0959-8049(18)30725-1/fulltext which reported the following Results and Conclusions: Results A total of 69 of 562 patients (Eastern Cooperative Oncology Group performance status 0–1 69%) were rechallenged with CABA (25 mg/m2 q3w, 58%; 20 mg/m2 q3w, 27.5%; other, 14.5%) for 1–10 (median 6) cycles; 76.8% received prophylactic granulocyte colony-stimulating factor. Median radiological or clinical PFS with CABA rechallenge was 7.8 months and 11.9 months with initial CABA therapy. OS was 13.7 months (95% confidence interval [CI]: 9.3–15.7) from the first CABA rechallenge cycle, 59.9 months (47.8–67.1) from the first life-extending therapy in mCRPC and 78.3 months (66.4–90.7) from mCRPC diagnosis. Best clinical benefit was improved (34.3%) or stable (47.8%). Lack of response to rechallenge occurred in 17.9% of patients (3.1% with initial CABA). The level of prostate-specific antigen decreased by ≥ 50% in 24% of patients at rechallenge (71% with initial CABA). There was no grade ≥III peripheral neuropathy or nail disorders. Conclusions CABA rechallenge may be a treatment option without cumulative toxicity in heavily pretreated patients with mCRPC who are still fit and had a progression >3 months after the last CABA injections.
  2. Jim Marshall (not a doctor) said … One of the most important meetings of doctors for men with advanced prostate cancer is the ASCO (American Society of Clinical Oncology) meeting held each year. Yesterday at the ASCO meeting Dr Maha Hussain, on behalf of her team presented the initial results of the PROSPER clinical trial. That trial tested whether men with no metastases, but who had rapidly rising PSA, would do better with early Enzalutamide (Xtandi). This presentation is just the start of scientific reporting. Dr Hussain is presenting this study to hundreds of her colleagues so they can absorb and criticize it. Only if it stands up against criticism will doctors add it to their armament. Basically, if you had no visible metastases and your PSA was rapidly rising, starting Enzalutamide would delay the appearance of mets by 3 years (compared to about 1 year with no Enzalutamide). Your PSA on Enzalutamide would stay steady for 33 months (compared with 4 months). This report is just a progress report, so details of whether your life will be extended will have to wait (but the figures are looking hopeful). Eligible men had no identified mets, PSA doubling time of up to10 months and a PSA of 2 ng/mL or higher. (Thanks to member David Prestridge for spotting the pre-meeting reporting of this and alerting us to this.) ... end Jim The ASCO Post reported these key points yesterday: The median for the primary endpoint, metastasis-free survival, was 36.6 months for men who received enzalutamide compared to 14.7 months with ADT alone. Patients who received enzalutamide plus ADT had a 93% reduction in relative risk of PSA progression compared to patients who received ADT alone; enzalutamide plus ADT delayed the median time to PSA progression by 33.3 months vs 3.9 months with ADT alone. Enzalutamide plus ADT prolonged the median time to first use of new antineoplastic therapy by 21.9 months vs ADT alone (39.6 vs 17.7 months), a 79% relative risk reduction. [jm: antineoplastic therapy = next anti-cancer drug.] A link to an ASCO abstract. This link may not have a long life. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC).
  3. Last Friday 10 March 2017 the Pharmaceutical Benefits Advisory Committee (PBAC) reached its initial decisions on drugs to go onto the PBS at reduced prices. This included whether to put Xtandi (Enzalutamide) before chemo on the PBS. The company will be told of the result next Friday 17 March 2017. If necessary, negotiations between the PBAC and the company continue for 4 weeks. The final results will be published on the PBAC website 21 April 2017. (If the company is not happy with the result, they have until July 2017 to appeal.)
  4. Thank you if you have sent in a submission. Thank you if you have considered sending in a submission, but felt you could not offer much. If you were leaving a submission until the last minute - that is NOW! Help get Xtandi (Enzalutamide) on the PBS for use BEFORE chemotherapy Click on this sentence to go straight to the PBAC to fill out the form. Click this sentence if you wish to see a short YouTube video about this. Click on this sentence to read about the drug and the online form. Closing date for comments is tomorrow Wednesday 8 February 2017 Late submissions will not be accepted.
  5. Details at the top of the page on: JimJimJimJim.com Click this sentence to go there. A gunner is a person who talks a lot about what he's going but doesn't' get around to doing it. "Gunna" (slang) = "going to" This is the last week before the public consultation closes next Wednesday 8 February. The Government is considering listing Enzalutamide (brand name Xtandi) on the Pharmaceutical Benefits Scheme (PBS) before chemotherapy. It's important that Australian men with prostate cancer, their partners,their families and their friends make submissions telling the Government that they support it making Enzalutamide available on the PBS before chemo. The more submissions that are received by the PBAC,the greater the prospect of Enzalutamide being listed on the PBS. It's not hard to make a submission. It doesn't take long. In his previous post Jim explains what to do. Your feedback is important & can make a difference. Please help us with our campaign. Don’t be a gunner.
  6. Some members needed more technological help to find the form and the video. Here 'tis. Cheers. Jim Help get Xtandi (Enzalutamide) on the PBS for use BEFORE chemotherapy Click on this sentence to go straight to the PBAC to fill out the form. Click this sentence if you wish to see a short YouTube video about this. Click on this sentence to read about the drug and the online form. Closing date for comments is Wednesday 8 February 2017
  7. The opportunity There is a chance to have your voice heard on whether the drug Xtandi (enzalutamide) should be available on the PBS BEFORE chemotherapy. Timing Submissions are due Wednesday 8 February 2017, and no late submissions will be accepted. Enzalutamide on the PBS An important drug for men with advanced prostate cancer is Xtandi, also called enzalutamide. The first evidence that enzalutamide worked looked at using enzalutamide AFTER the chemotherapy drug docetaxel. A committee of experts looked at this evidence. They recommended that it was worth spending taxpayer money on. So, now men with advanced prostate cancer can get enzalutamide on the PBS at a low price, AFTER they have had chemotherapy with docetaxel. Some new evidence has arrived showing that enzalutamide works well BEFORE chemotherapy with docetaxel. The same committee of experts is now looking at this evidence to see if it is worth spending taxpayer money to put enzalutamide on the PBS for use BEFORE chemotherapy with docetaxel. This is the second time this has come up for consideration. The first time, the expert committee rejected the application: because the submission was focused on a claim of survival advantage, which was small and uncertain, rather than on outcomes that clinicians and patients considered to be of most value. The purpose of using enzalutamide earlier in the disease pathway would be: 1) to delay symptoms from developing and maintaining a better quality of life for longer in asymptomatic patients for whom placebo, or watchful waiting, is the appropriate comparator; and 2) delaying the toxicities of chemotherapy in symptomatic patients considered suitable for docetaxel. That committee has asked for public submissions for a new application. Enzalutamide BEFORE chemotherapy The first thing you should understand that enzalutamide is not a miracle cure. About half the men on the PREVAIL clinical trial were still alive three years after they started on enzalutamide. Some of the men who responded will have a much longer survival. I have met a man whose cancer has been kept at bay for 6 years so far on enzalutamide. But survival times pre-chemo and post-chemo are not different enough to convince the experts. What is most important about this drug is the quality of life it makes possible during that two or three years. Docetaxel chemotherapy vs enzalutamide side effects The first thing you should understand is the current first treatment at this stage - docetaxel chemotherapy. Many men report coping quite well with their docetaxel, finding the temporary hair loss and other side effects manageable. But some men have a terrible experience with the side effects. It is so bad for some men that they give up the treatment. And, about one man in four hundred dies from the treatment. On the other hand, enzalutamide treatment has far fewer reported side effects. Fatigue and hypertension were the most common. So, the first benefit of starting enzalutamide BEFORE chemotherapy is that a man can delay the start of the docetaxel chemotherapy. The PREVAIL clinical trial In the PREVAIL clinical trial of enzalutamide before chemotherapy, men had to: have metastatic prostate cancer, be castrate resistant, and have no, or few symptoms (like pain). Metastatic means that their prostate cancer had spread to other parts of their body. Castrate resistant means that the primary hormone therapy, with drugs like Zoladex, Lupron, and Eligard, was no longer able to keep the cancer in check by itself. In other words their PSA was rising, despite the hormone therapy keeping testosterone very low. Men in this trial on enzalutamide did not need to start chemotherapy, on average, for more than two years - 28 months. The control group of men had to start chemotherapy after 11 months. So men on enzalutamide had 17 MORE months at a higher quality of life. After 12 months of treatment, 65% of men treated with enzalutamide had scans which showed no progression of their cancer, compared to 14% of the control group. The trial was finished early when it became clear that the enzalutamide was far more effective. At that stage, 29% fewer men had died in the enzalutamide group. The enzalutamide group also had a longer time until the first skeletal-related event (that is, problems with their bones). Most prostate cancer metastases (about 89%) occur in bones. Of the men with metastases away from their bones, complete or partial soft-tissue response favoured enzalutamide 59% to 5%. Time until PSA started going up again also favoured enzalutamide. So did the number of men whose PSA dropped to at least half - 78% to 3%. Submissions The Prostate Cancer Foundation of Australia (PCFA) is making a submission on behalf of its members. Some individual members have told me that they are going to put in an individual submission. If you also wish to have your say, a couple of points: Firstly, while submission sounds grand, it is as easy as filling in a few boxes on a web page: Click on this sentence for the submission form. OR Here. Notes on the boxes on that page: Medicine to which this submission relates: Enzalutamide Date of PBAC meeting: March 2017 Note: This is when the board meets. It is not the due date for submissions which is Wednesday 8 February 2017. First declaration box: Nil (unless you work for the manufacturer, hold shares in the company, etc.) Second declaration box: Say what you are: man with this disease, partner, friend, doctor, etc. Say where you are in your disease: having the drug, missed out on the drug, expecting to be needing the drug in the future. What comments would you like the PBAC ...? • How does this condition/disease affect quality of life? • What would you most like to see from this treatment? Improved side effects? Slowing disease progression? More mobility? Other benefits? • If you have used or prescribed this new medicine, what was your experience of the beneficial effects? • If you have used or prescribed this new medicine, what side effects or toxicities did you experience or observe? • If you haven't used the new medicine yet, what are your expectations of it? • If you use other currently available therapies or medicines you use to manage your condition (or for prescribers, for your patient’s condition), what are the benefits and/ or the challenges? Where did you obtain the information that helped form your views on this treatment? ◦ I have been a patient on this medicine; ◦ Your doctor; ◦ Other patients stories/experiences ◦ Professional colleagues; ◦ Support networks: PCFA, Australian Advanced Prostate Cancer Support Group, JimJimJimJim ◦ Own research; ◦ Other patient resources; ◦ Direct experience as a health professional or carer; ◦ Other – please provide details. When your entry is complete be Very Careful not to press the wrong button. Tick: Agree to terms and conditions Click: Submit Click on this sentence for the submission form. Lets hope for a good result this time! Jim
  8. 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.
  9. Apalutamide (JNJ-56021927 formerly known as ARN 509) is a novel small-molecule androgen receptor antagonist similar to enzalutamide but with less central nervous system penetration, which could potentially result in reduced levels of fatigue and seizures. Curetoday.com has an article about 2 Phase 3 clinical trials of Apalutamide: the ATLAS trial (NCT02531516; learn more here); the SPARTAN study (NCT01946204; learn more here). The SPARTAN study is currently recruiting in Australia; the ATLAS study is not. For SPARTAN, eligible patients must show no signs of evident metastatic prostate cancer and must have a high risk for disease progression. A high risk for disease progression is defined as either a PSA doubling time (PSADT) of less than 10 months while on continuous ADT, or Castrate Resistant Prostate cancer demonstrated while on continuous ADT. PSADT is calculated using at least three PSA values during ADT.
  10. The New Prostate Cancer Infolink has an article about the announcement of a new clinical trial of Enzalutamide (brand name Xtandi) in men with metastatic, hormone-sensitive prostate cancer. This trial will be recruiting men In Australia. The New Prostate Cancer Infolink expresses concern about the suitability of this trial for men newly diagnosed with a significant presence of metastatic disease. Click on this link to read the article.
  11. 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?
  12. 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
  13. Paul Edwards

    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
  14. At its November meeting the Pharmaceutical Advisory Committee (PBAC) considered an application to extend the listing of enzalutamide (brand name Xtandi) to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel (chemotherapy). The PBAC has released its decision on the application. It is what the PBAC describes as a "1st time decision not to recommend". It's disappointing that the application was not successful but encouraging that the PBAC is asking Astellas to resubmit the application. Here is the full decision from the PBAC: "The PBAC decided not to recommend extending the PBS listing of enzalutamide to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel because the submission was focused on a claim of survival advantage, which was small and uncertain, rather than on outcomes that clinicians and patients considered to be of most value. The purpose of using enzalutamide earlier in the disease pathway would be: 1) to delay symptoms from developing and maintaining a better quality of life for longer in asymptomatic patients for whom placebo, or watchful waiting, is the appropriate comparator; and 2) delaying the toxicities of chemotherapy in symptomatic patients considered suitable for docetaxel. The PBAC noted the median time to initiation of cytotoxic chemotherapy in the PREVAIL trial was 28.0 months in the enzalutamide group versus 10.8 months in the placebo group, a median difference of 17.2 months, which was clinically meaningful. In contrast the overall survival gain of 4 months for enzalutamide in the same trial compared to enzalutamide in the post-docetaxel setting (4.8 months from the AFFIRM trial) highlighted the minimal impact of earlier enzalutamide treatment on overall survival. The PBAC therefore rejected the application because it did not appropriately reflect the value of early enzalutamide treatment. The PBAC encouraged a resubmission to evaluate the potential gains in quality of life based on the patient populations and outcomes described above". The Drug Company commented: "Astellas is disappointed not to have secured an extended PBS listing for patients with mCRPC who have not had prior docetaxel, but is grateful to the PBAC for their helpful feedback and advice."
  15. At its November meeting the Pharmaceutical Benefits Advisory Committee was considering whether Enzalutamide ( Brand name Xtandi) should be made available on the Pharmaceutical Benefits Scheme (refer to this previous post on the subject) One of the members in last week's teleconference asked when would we know the outcome of that meeting? Today the Pharmaceutical Benefits Advisory Committee published the outcomes from its July meeting. At this rate we won't know the outcomes of their November meeting until April next year. [Edit 18 December 2015 PBAC published its recommendation. Click on this link to find out more.]
  16. 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.
  17. According to this WebMD paper, for patients prescribed the anticoagulant (blood thinner) warfarin there is a long list of medications that both patient and treating doctor must be aware as causing severe to serious to moderate side effects: http://tinyurl.com/qcafmkw Interesting, among them, are several that prostate cancer patients are prescribed including NSAIDs (identified here http://tinyurl.com/nhtjyvh), enzalutamide, corticosteroids (thus prednisone if prescribed abiraterone), acetaminophen, and several others. If you're a patient prescribed warfarin and also prescribed any of the medications listed, best to discuss with your treating doctor in order to watch diagnostics closely if the combination of these medicines with warfarin is necessary.
  18. The American Prostate Cancer Foundation identified 8 highlights from this year's Annual Meeting of the American Society of Clinical Oncologists (ASCO).
  19. PLATO is a 2 stage Clinical Trial with 500 patients (80% in Australia, rest in Finland, UK and USA). On Stage1 everyone gets Enzalutamide (no placebo). [Xtandi is the brand name for Enzalutamide] Those continuing in Stage 2 are randomised: 50% of patients to Abiraterone plus placebo and 50% of patients to Abiraterone plus Enzalutamide. Both arms in Stage 2 also get Prednisone to go with the Abiraterone. Stage 2 is double blind so neither doctor or patient know which arm you are in. Also in Stage 2 they do not do PSA tests but track the tumour with scans. That sounds a little scary! If I get twitchy, I may have to cheat – or just turn off the brain, lie back and think of England. To qualify for Stage 2 you need to continue to meet the original general requirements for the trial. The original changeover point from Stage 1 to Stage 2 was defined as a 25% increase in PSA over a 1 or 2 month period following the nadir (lowest point). This has now been relaxed by adding a second additional requirement – growth in tumours or metastases as shown by CT or bone scan. All men on the trial had to have CT or bone scan visible tumours or metastases at the start of Stage 1. My tumour was only discovered at PSA 70 just before start of Stage 1. Given they now know where it is, they may be able to track its growth at lower PSA’s but the effect of adding this second requirement would likely give me more time on Stage 1 than originally which should be a positive – my tumour is probably currently invisible at PSA 13. I have a Clinical Trial consultation every 4 weeks and, of course, I chat with the other guys in the waiting room – and they with me. I started the trial in June 2014 – most guys started between Jan 2014 and June 2014. Their PSA’s at start of the trial vary a lot – 30 to 500 on the guys I have talked to. All seem to be getting a reasonable response but the details vary a lot – how fast it drops, how low it goes, how long it stays there etc etc. I have not spoken to anyone yet who is on stage 2. With the trial we are doing two sequences of PSA tests to monitor results: 1.Local pathology lab (Douglass) Results 65 (June 14), 38, 25, 15, 20 (end Nov) and 13 (23 Dec) 2.Official trial pathology lab in Singapore Singapore result end Nov was 14. It looks like my PSA results are bottoming out in the 10-15 range and the local end Nov result is incorrect. What side effects have I had from my treatment so far on the trial? My main side effect from Lucrin over the last 11-12 years has been fatigue – in my case always there but manageable. The only side effect I get from Enzalutamide is substantially increased fatigue – to the point of needing a doze most afternoons. Talking to doctors and patients, substantially increased fatigue is the main Enzalutamide side effect for most men.
  20. AR-V7 is an androgen receptor variant which, if found in the blood stream, disables the effectiveness of either Xtandi/enzalutamide or Zytiga/abiraterone acetate. I have prepared a summary of recent research about AR-V7 which is available at http://tinyurl.com/qbgpezo [Ed - Chuck's paper mentions blood tests for Circulating Tumour Cells (CTC) and AR-V7. These tests are not routinely available in Australia.]
  21. 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.
  22. Paul Edwards

    Enzalutamide Clinical Trials in the news

    A good article in today's Australian Financial Review (16 April 2014) about the 2 Clinical Trials for Enzalutamide that are currently recruiting.
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