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  1. Jim Marshall (not a doctor) said ... In this video Prostate Cancer Research Institute Executive Director Mark Scholz talks about a clinical trial for men who are metastatic and have rising psa on hormone therapy. The trial is testing whether adding the PARP inhibitor Lynparza (olaparib) to the super-hormone Zytiga (abiraterone) increases its effectiveness. You can find out about the clinical trial at: https://clinicaltrials.gov/ct2/show/study/NCT03732820?show_locs=Y#locn Details there include: inclusion details (things you need to get into the trial); exclusion details (what will keep you out of the trial); and locations. Australian locations include: Box Hill, Australia, 3128 Darlinghurst, Australia, 2010 Greenslopes, Australia, 4120 Herston, Australia, 4029 Kingswood, Australia, 2747 Kurralta Park, Australia, 5037 St Albans, Australia, 3021 Waratah, Australia, 2298 As always, ask your doctor if you think this might be for you. ... end Jim
  2. 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.
  3. 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.
  4. Charles (Chuck) Maack

    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
  5. 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.
  6. 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.
  7. Paul Edwards

    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
  8. 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..
  9. Jim was away in Sydney with a swag of other members representing our group at a meeting with Janssen, the suppliers of the drug Zytiga. As a result of this, Jim asked me to chair our phone in conference in his absence. We had no guest speaker at our gathering which made life a little easier for me as our talks would be based on a round table discussion among members. I had the feeling it might be a bit dull without a guest and members be reluctant to come forward and speak on issues. With this in mind I prepared some topics prior to the meeting just in case. I needn't have worried as right from the beginning we were off and running and I threw my cheat sheet into the bin. The meeting never ran out of steam and everyone contributed some great stuff for contemplation so much so that I decided to contribute this summary. I did not record any of our discussions so what I present here is from hurried notes and memory. It is subject to my interpretation and in some areas may be incomplete or inaccurate for which I apologise in advance. I received 8 apologies (most of which were from the members attending the Janssen meeting). There were 6 participants who took part in our meeting and I hope they were happy with the results of our gathering. The session began with a briefing by me as per my understanding of the meeting with Janssen being attended by the cream of our membership and with what little I knew of the nuts and bolts of that meeting I was only able to offer a broad assumption. Jim, I understand will be responding to members with a full report at some time in the future. Two men gave a report on exercise programs they were attending. One man is participating in a study at St Lucia University that includes dietary analysis and different exercise regimes. He intends to post a report on the program when he is able. However he stated that he might need assistance in getting the report ready for posting and has asked if any of the members would be able to assist. I can pass on contact details to any member willing to help out. The second man is on an exercise program at Deakin University Burwood Campus Melbourne that is oriented specifically to prostate cancer patients. In further talks on exercise programs and the relationship with the application of chemotherapy, the subject of a recent “Catalyst” program was raised. As can be seen in the Catalyst program there is a gym adjacent to the chemotherapy section where patients are encouraged to exercise straight after infusion of their chemo. This is believed to help increase blood flow to assist in the uptake of the chemotherapy drugs more effectively and improve the body's own immune system. Here is the link on Iview. this link It was also raised that jimjimjimjim had a guest speaker a couple of years ago during a phone in called Dr Prue Cormie. The minutes of that meeting can be found by clicking on this link. Also an interesting video talk by Dr Prue Cormie can be found by clicking on this link. [Edit - The Catalyst program featured Professor Rob Newton from Edith Cowan University in Perth. Dr Prue Cormie was previously at Edith Cowan but is now at the Australian Catholic University, Melbourne.] One man gave a report on his treatment involving a small trial using Lutetium 177 which is still ongoing. His initial thought was that about 10% patients have reported excellent results while he feels he has had moderate results with little side effects, mainly a sore throat and dry mouth as the radionuclide targets PSMA cells but also effects saliva glands. An interesting issue caught my ear in this discussion, regarding access to results while on a trial. If my memory serves me correctly, it appears that patients taking part in a blind trial are not given access to any pathology test results while on the trial. This is something I have not considered before, but I can see the point in keeping this information secret during a trial of this sort. However it is something to consider for those looking for trials to volunteer for. Perhaps other members may be able to confirm or deny my limited knowledge on this matter, as for Lutetium 177 more can be read by clicking on this link. A man gave a report on his experience with treatment using docetaxel and recommencement of ADT. His experiences were not good and included peripheral neuropathy particularly in legs ankles and feet, constipation, headaches, nausea and fatigue. This has taken 11 weeks to finally start to resolve since completing chemo. It has brought his PSA back down to an acceptable level though. A man also reported he was diagnosed with radiation cystitis some time ago and experienced bleeding and urine blockages, similar to my experience in 2014. He also was treated with hyperbaric oxygen treatment in a decompression chamber but in his case the treatment was successful. I congratulated him and passed the comment that thanks to his report I can consider a 50-50 success rate in this treatment. A bit unfair from me I know but it was written in jest and I include it here to present as a successful case in the use of this treatment for radiation cystitis. A man reported a rising PSA after intermittent ADT over the past 10 years since initial primary treatment. Recently he has been back on Lucrin but his PSA is doubling monthly. He was not looking forward to being advised to begin chemotherapy before being considered for enzalutimide or zytiga. After much discussion it was suggested that he should approach his GP, urologist or oncologist regarding this matter and perhaps a second or third opinion before any choice is made. The meeting concluded approx 1120 hrs. Lee Gallagher (Popeye)
  10. You will have noticed that the other members of our Executive Committee (Alan Barlee, Nev Black, Paul Hobson, Tony Maxwell) make an enormous contribution to our monthly phone-in meetings, to information and discussion posted on our website (JimJimJimJim.com), and to general support of our members by phone, email, and at Face-to-a-name members' meetings. What you may not be aware of is that your Executive Committee also spends much time and effort in advocacy duties on behalf of the group. Below are some advocacy events held during the past year. Please be aware that where I am listed as the sole attendee below, most often, most of the background work has been done by other members of the Executive Committee. Health Week Launch This event, co-sponsored by the Prostate Cancer Foundation of Australia (PCFA) and Astellas (vendors of Xtandi (enzalutamide)) was a press briefing in Sydney to help the press focus on actual men with advanced prostate cancer in their Health Week reporting. After a formal presentation, Paul, Alan, Tony and I joined PCFA CEO Anthony Lowe in one-on-on discussions with members of the press about advanced prostate cancer and with Astellas staff about getting Xtandi (enzalutamide) on the PBS pre-chemotherapy. Later in the day I caught up with Sydney members of our group, and in the evening attended the Westmead Prostate Cancer Support Group. Before flying back next morning I met with Professor Peter Croucher at the Garvan Institute of Medical Research to discuss the research Professor Croucher's team is doing on finding and treating cancer that moves to bones. Multi-parametric MRI scan and biopsy The Medical Services Advisory Committee (MSAC) is an independent expert committee that recommends to the Minister which procedures should go on the Medicare Benefits Schedule (MBS). A multi-parametric MRI is a scan which can show more detail of prostate cancer, especially in the prostate. Australia's Radiation Oncologists made an application to have the multi-parametric MRI made a Medicare item. Your Executive Committee made a submission on your behalf to the MSAC supporting this application. Pharmaceutical Benefits Advisory Committee (PBAC) review The PBAC is the independent expert committee that recommends to the Minister which drugs should go on the PBS. You may remember that, as the result of submissions by our group and of many personal submissions on the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) that I was invited to appear before the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia. Just one week after the Inquiry ended, Minister for Health Sussan Ley announced a review of the PBAC to "address technical methods issues raised by the PBAC and stakeholders". A team at the University of Adelaide prepared a new set of guidelines for the operations of the PBAC, and Tony Maxwell and I attended the PBAC Guidelines Review - Presentation Forum in Sydney. Amongst a large group of pharmaceutical and medical experts, Tony's contribution beginning "I am a patient ... " had a striking effect. With not enough room for my scooter in the morning tea room I had to stay in the main auditorium. The only other person there was PBAC Chair, Professor Andrew Wilson, setting up his slides. When he finished setting up, he came over and we had quite a long and productive talk. Office of the Minister for Health All members of your Executive Committee met with Mark Kinsela, Senior Advisor to the Minister for Health at the office of the Minister in Canberra to discuss issues of import to men with advanced prostate cancer. In the generous 1 hour 20 minutes we were given we were able to cover many issues, and felt we were given a well-informed and probing hearing. Access on the PBS to the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) before chemotherapy, and access on medicare to the radiotherapy drug Xofigo (Radium-223) were, of course an important focus of the discussion. PCFA support groups meeting I met with PCFA senior staffers Amanda Pomery (National Manager, Support & Community) and Katie Dundas (Manager, Community Awareness and Education) a few weeks ago to talk about our issues as a support group. The changes that are happening to our website at the moment, and the new flexibility we have with our phone-in meetings are a couple of the results. (Our next phone-in meeting will be an early evening one - a roundtable at 5:30 pm on Friday 24 June 2016.) Getting Bayer Xofigo on Medicare Earlier this month when plans for a meeting at Bayer in Sydney fell through, senior staff of Bayer Pharmaceutical and PCFA CEO Anthony Lowe flew to Brisbane to speak to me about the problems of getting Xofigo (Radium-223) on Medicare, as a result of a letter your Executive Committee had sent to Bayer. It turned out that Bayer now feels able to re-reconsider an earlier approach they had abandoned, and that as a result of our discussion on Medical Services Advisory Committee (MSAC) guidelines they will more clearly identify the logjams and get back to us. Election 2016 Your Executive Committee had made suggestions to PCFA about presenting a comprehensive policy document to parties for their support. Meeting with PCFA CEO Anthony Lowe, I came to support his opinion that a single policy item presented to all party leaders in person by Anthony would be in the best interests of men with prostate cancer. Executive Committee members concurred later in the day. One week later, while visiting Launceston General Hospital in Tasmania, Shadow Minister King announced that the Labor Party has committed to securing the existing Department of Health funded prostate cancer nursing positions for a further 3 years from 30 June 2017 and will fund an additional 14 prostate cancer nurses across Australia. Anthony was scheduled to meet with other party leaders. Getting Zytiga (abiraterone) on PBS pre-chemotherapy Your Executive Committee sought to meet with Janssen (a Johnson & Johnson subsidiary) to discuss progress on getting Zytiga (abiraterone) on the PBS pre-chemotherapy. As a result, Janssen brought together a Prostate Cancer Patient Working Group meeting in partnership with PCFA last Friday 27th May 2016 in a meeting room at Sydney Domestic Airport. Anthony Lowe and Katie Dundas of PCFA, Paul Hobson, Alan Barlee, Nev Black, Graham Bloomfield, Kerry Drinkwater, David Abrahams, Zeni Muhiji and I attended. Several of those attending had abiraterone experience. We heard a presentation from Prof Gavin Marx on current therapeutics in advanced prostate cancer, and had some hours talking with Janssen staff about issues. Disclosure Your Executive Committee and other members taking part in the above advocacy activities above have signed various commercial-in-confidence agreements and will not be free to discuss details in those cases. Only one of the activities listed above included a financial recompense for time contributed. PCFA contributed travel costs in several cases, but travel and accommodation for the Canberra meeting were met by committee members themselves. Personal note An amazing thing about the Executive Committee members who assist me in running the Australian Advanced Prostate Cancer Support Group is that, as well as the enormous work they do for us, each takes a central role in their local Prostate Cancer Support Group, and on various research project teams, and general prostate cancer activities, stepping forward whenever a person is needed. We have made great strides with our advocacy in the past three years. Members' submissions to the PBAC have paid an important part. But on top of that, the vital part paid by the other members of the Executive Committee, especially in the past year, had laid an important foundation for the next year. We can look forward to the reform of the PBAC/PBS process and hopefully getting pre-chemo approval for Zytiga, Xtandi and Xofigo at least. I am proud to work with these men and with this group. Jim Marshall Convenor Australian Advanced Prostate Cancer Support Group
  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. 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
  13. 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.]
  14. Paul Edwards

    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
  15. 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.]
  16. Patients taking Zytiga need to be aware that Zytiga may have adverse interactions with many common drugs. This is because many doctors are unaware of these drug interactions. So long as you are aware of this issue, it can be easily managed. It does not mean that you should stop using Zytiga. This is one of the key messages in the most recent video (28 August 2014) by Dr Charles Myers Jnr (nickname Snuffy Myers) in which he talks about Zytiga. See this Dr Myers Video at: http://askdrmyers.wordpress.com/2014/08/28/zytiga-pca-remissions/ OR http://tinyurl.com/mggrz7x
  17. 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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