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  1. The trial is titled "Using Theranostics Early to Eradicate Prostate Cancer and Developing Novel Strategies for PSMA Negative Disease". These clinical trials are headed by Prof. Michael Hofman and A/Prof. Arun Azad of Peter Mac. Recruiting is expected start early next year.Details of these trials will follow later this year. In essence, Lutetium will be given earlier in the piece, Lutetium will in special circumstances be given prior to robotic surgery, Research will commence into CAR T cell treatment for prostate cancer which is not PSMA avid and cannot currently be treated using Lutetium. A dedicated team of specialist Doctors,Scientists and Clinical Researchers at Peter Mac have just successfully applied to the Movember/ Cancer Australia Prostate Cancer Research Alliance for funding of these new Lutetium trials. (see details by clicking this link to the Peter Mac site) http://tinyurl.com/y36xuwqg This is a world-class proposal from a world-class multi-institutional Australian team. Movember and Cancer Australia will jointly provide $4M in funding to the Alliance. In addition generous financial support for these trials totalling $1.4M will also be provided by Peter Mac Foundation, University of Melbourne, Victoria Cancer Agency, Monash University, Epworth/E.J Whitten Foundation, Peter Mac Research Division. This funding will be used solely for prostate cancer research The grant interview team for this project consisted of Prof. Michael Hofman, A/Prof. Arun Azad, A/Prof. Declan Murphy and yours truly as a consumer representative. Hopefully these trials will provide a quantum leap forward for prostate cancer treatment.
  2. Jim Marshall (not a doctor) said ... The clinical trial testing Lutetium-177 therapy against the existing standard therapy (Cabazitaxel (Jevtana)) is taking its first men. It starts at the Peter MacCallum Cancer Center in Melbourne (PeterMac), and other sites will be progressively added. The Prostate Cancer Foundation of Australia (PCFA), with which we are affiliated, has co-sponsored the trial. Below is the message that Daniel Moore of PCFA sent announcing the start. ... end Jim In July 2017 PCFA and ANZUP launched the first Australian trial of a ground-breaking nuclear medicine treatment (Lutetium – 177 PSMA radionuclide therapy) for men with advanced prostate cancer, the TheraP Trial. Today we are pleased to announce this trial is open at Peter MacCallum Cancer Centre in Melbourne with the additional sites to open in the following months. This is an exciting trial and we are aware that you may have members of your group or the community ask you for further information. It is important to remember this treatment won’t be suitable for all those who have prostate cancer. As such, for further details and advice regarding eligibility, please ask anyone interested to print off the trial and contact details from the Australian and New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=6899&isClinicalTrial=True) and speak with their treating physician. To learn more, please view the information page via ANZUP here: http://www.anzup.org.au/content.aspx?page=lutetiumprostatecancertrial.
  3. 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.
  4. "Bipolar Androgen Therapy" (BAT) involves alternately flooding and starving the body of the male hormone testosterone. Last year the forum had a post about a small study of 16 men which tested Bipolar Androgen Therapy: click here to read that previous post. The same researchers have now reported on a larger study with 47 Participants; click here to read about this study. Dr Matt Hobbs, deputy director of research at the charity Prostate Cancer UK, warned: "this is early stage research and further studies are needed in order to understand exactly how intriguing developments like this work and to test the findings more robustly in large clinical trials."
  5. Several of our members have been participating in a clinical trial of Lutetium (Lu 177) being conducted at the Peter MacCallum Cancer Centre in Melbourne, Click here to read an article published in the Australian Financial Review about this clinical trial of Lutetium. A large randomised trial to test this treatment next year will be conducted in 2017.
  6. You may have heard on the news in the last day or so about how Keytruda, a drug used for melanoma, has produced good results in clinical trials to treat patients with lung cancer. Preliminary studies suggest that some advanced prostate cancer patients may respond well to Keytruda and futher clinical trials with prostate cancer patients are being planned. Click here to read a news article about the results of the clinical trials with Keytruda and lung cancer patients.
  7. At our phone-in meeting last Friday medical oncologist Professor Ken Ho and urologist Dr Ano Navaratnam spoke to us about their clinical trial looking to prevent and reverse the muscle wasting that occurs in men on hormone therapy (ADT). You will recall that the initial pilot phase of the trial is only available in Brisbane, Australia. Details Opportunity to Participate in World First Clinical Trial Are you a male who: • Has Prostate Cancer • On Androgen Deprivation (also known as “Hormones”) • Independent in your activities of daily living You may be eligible for our trial to prevent and reverse muscle wasting that occurs in men on “Hormones” Contact: Dr Irina Oleinikova Study Coordinator Princess Alexandra Hospital Irina.oleinikova@health.qld.gov.au Phone: 3176 2217 or 0402 159 586 Dr Ano Navaratnam Urology Fellow Princess Alexandra and Greenslopes Hospitals, navs_ano84@hotmail.com Supported by: Click here to download this as a PDF; Muscle wasting prevention clinical trial.pdf
  8. Agenda Friday 26 August 2016 Please note This is a permanent change. We do not use 4444# any more. The phone numbers are unchanged. Urologist Ano Navaratnam (Urology Fellow Princess Alexandra and Greenslopes Hospital) and Medical Oncologist Ken Ho (Professor of Medicine, University of Queensland and Chair Centres for Health Research, Princess Alexandra Hospital, Brisbane) are conducting a clinical trial giving testosterone to men on hormone therapy (ADT). We are thrilled that they are both joining our phone-in meeting this Friday 26 August 2016 to tell us the details and answer our questions on the study. Join us this Friday morning! Disclaimer This Community does not give medical advice. No members are authorised to give medical advice. Ask your doctor if you hear anything here that you think may be related to your treatment. Time 9:30am - 11:00am Eastern Standard Time (Queensland) The formal phone-in meeting ends after 90 minutes. The lines are kept open for up to an hour after that for members to informally chat. Daylight savings times Brisbane 9:30am Sydney, Melbourne, Hobart: 10:30am Adelaide, 10:00am Perth 7:30am Winter times Brisbane 9:30am Sydney, Melbourne, Hobart 9:30am Adelaide 9:00am Perth 7:30am Daylight saving ends first Sunday in April Daylight saving starts first Sunday in October Dial in You must dial in - we do NOT dial you. Landline - Anywhere in Australia - 25 cents Phone numbers only available in members email. Mobile phone warning The costs of mobile calls are nothing to do with the Advanced Prostate Cancer Support Group or with PCFA. They are between you and your phone provider (Optus, Telstra, Virgin, Vodafone, etc). If you dial one of the capital city numbers given above from a mobile phone, the cost to you will be the cost on your mobile phone plan. If your plan gives you free, or low cost local calls, and you are in one of these cities, it should be free, or a local call. If your plan gives you free, or local cost national calls that should work too. Be sure - call your provider, give the number you might be calling, and check the cost for you to call that number. Speaking time We want many voices to be heard. If you are a member listed to speak below, the chair will probably expect you to take no more than about 5 minutes on presentation so there is plenty of time for others to respond. Special Guest Speakers are invited to speak for 10-15 minutes, then field questions. Guidelines No noise House - radio, TV, computer, pets, other phones, conversation Yourself - mute button, or mouthpiece away from mouth Phone - call waiting off (#43#), Mute button or hang up to leave the room. No mute button? ##4 to mute, ##5 to unmute. Cordless phone - don't carry, put on folded handkerchief to limit reverberation Other calls - Please do NOT use call waiting or another line on the same phone to take another call - members around Australia are left listening to your 'hold' music until you return. Speaker phone Please do NOT use a speaker phone, unless you are very good at keeping it Mute, and at lifting and using the hand piece when you wish to join in the conversation. Mobile phone You will need enough charge for the length of the call, or take the call with your charger plugged in. Speaking Speak clearly into mouthpiece in ordinary voice. Say who you are when signing in, and each time you speak. Listen for the gavel. The Chair may need to interrupt. It's a meeting of 20 people, not a simple phone conversation. If you are not one of the two people in the particular conversation at the time, keep your mute button down and let others contribute. Help the secretary by later emailing details for the minutes. Restarting You may hang up and sign in again as many times as necessary. Sometimes we may have to restart the meeting - dial in again. With everyone calling at once you may need to try more than once. Apologies From. Late starters Maybe you haven't had access to the agenda or you have late breaking news you would like to share. Tell the chairman here at the beginning of the meeting that you would like to speak, and he will fit you in - probably later, perhaps right now if that suits. Special expert guest speakers Urologist Ano Navaratnam (Urology Fellow Princess Alexandra and Greenslopes Hospital) and Medical Oncologist Ken Ho (Professor of Medicine, University of Queensland and Chair Centres for Health Research, Princess Alexandra Hospital, Brisbane) are conducting a clinical trial giving testosterone to men on hormone therapy (ADT). We are thrilled that they are both joining our phone-in meeting this Friday 26 August 2016 to tell us the details and answer our questions on the study. Other new stories or updates Any man who wishes to update us on his progress is welcome to contribute here. Formal end The Chair will declare the formal part of the teleconference closed at his discretion, perhaps around 11am. The teleconference lines will be kept open until at least 11:30 for anyone who wishes to continue discussions, update his health, or just chat. Informal chat Any topic you like - topics we didn't reach, something discussed earlier you wish to comment on, an update on your health, how your new boat is going, moaning about the weather, anything that you wish to say. Future phone-in support group meetings Fourth Friday of each month, except: January (one week late for Australia Day), March (one week early for Easter), and December (one week early for Christmas) Phone-in support group meeting dates 2016 June 24 July 22 (not the last Friday) August 26 September 23 (not the last Friday) October 28 November 25 December 16 (not the fourth Friday) Changes or questions If you wish to update us about any changes in your health or treatment, or have a question you would like answered or discussed, or you would like to talk about joining a teleconference group, let us know. Then we can put it high on the agenda so it doesn't get lost - just reply to this email, or use Contact Jim on JimJimJimJim.com. This message has been send to you because you are a member of an Advanced Prostate Cancer Support Group. Visit JimJimJimJim.com and click on Contact Jim if this is a problem.
  9. Treating the prostate tumour is generally not considered an option if a patient has metastatic disease. Instead, patients are treated with systemic therapies, starting with androgen deprivation therapy. Recent data has suggested that removal of the primary tumour could enhance cancer control and survival in some patients but there is no evidence in the form of clinical trials to support this. Researchers at The University of Texas MD Anderson Cancer Centre have now begun a clinical trial to determine whether treating the primary tumour has any oncologic benefit in patients with metastatic prostate cancer. In the trial patients with metastatic prostate cancer receive systemic hormone treatment for 6 months and then are randomly assigned to continue hormone treatment only or continue hormone treatment and also undergo definitive treatment of the primary tumour. Dr Ana Aparicio, a one of the researchers in the trial said: “We think treating the primary tumour will help some people a lot, some people a little, and some people not at all. It is too early to recommend definitive intervention to the primary tumour as standard therapy in patients with metastatic prostate cancer outside a clinical trial.” More information about the trial is available at http://www2.mdanderson.org/depts/oncolog/articles/14/3-mar/3-14-3.html
  10. Trial stopped - see below. Men who are on androgen deprivation therapy and who have metastases may be interested in the following Phase 3 clinical trial: A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC (ARMOR3-SV) Details of this trial are available at XXXXXXXXX To be eligible, you must not have been treated with abiraterone, enzalutamide or chemotherapy. You must have detectable AR-V7 (your circulating tumour cells will be tested as part of the eligibility process). If accepted for the trial, you will receive active drugs, not placebos. You will receive either Galeterone or Enzalutamide. Galeterone (TOK-001) is a new steroidal antiandrogen under development by Tokai Pharmaceuticals for the treatment of prostate cancer. It possesses a unique dual mechanism of action, acting as both an androgen receptor antagonist and an inhibitor of CYP17A1, an enezyme required for the biosynthesis of the androgens. Galeterone may benefit men who carry the AR-V7 subtype of Castrate Resistant Prostate Cancer and who therefore do not respond well to treatment with either abiraterone or enzalutamide. The trial is currently recruiting participants at the following Australian trial sites listed below: Peter MacCallum Cancer Centre, 2 St. Andrews Place, East Melbourne, VIC, 3002 North Coast Cancer Institute,Wrights Road, Port Macquarie, NSW, 2444 Ashford Cancer Centre/Adelaide Cancer Centre Research, 520 South Road, Kurralta Park, NSW, 5037 Box Hill Hospital, Monash University and Eastern Health Clinical School, Level 2, 5 Arnold Street, Box Hill, VIC, 3128 Macquarie University, Urology Macquarie University Clinic Suite 304 Level 3, 2 Technology Place, Sydney, NSW, 2109 Cabrini Hospital,Suite 19, 183 Wattletree Rd, Malvern, VIC, 3144, AU ICON Cancer Care, 39 White Street, Southport, QLD 4215 Monash Medical Centre, East Bentleigh, 865 Centre Road, East Bentleigh, VIC, 3165 Peninsula Specialist Centre, 101 George Street, Kippa-Ring, QLD 4021 Princess Alexandra Hospital, Ipswich Road, Woollongabba, QLD, 4102 St. George Private Hospital, Oncology Day Care Centre, 1 South Street, Kogarah, NSW, 2217
  11. Trial stopped - see below Thanks for Chuck Maack for alerting us to this. Galeterone (TOK-001) is a highly selective, multi-targeted, oral small molecule, drug candidate for the treatment of prostate cancer that disrupts androgen receptor (AR) signalling, the key driver of prostate cancer growth, via multiple mechanisms of action: androgen receptor degradation, which reduces the amount of androgen receptor protein in the tumor cells; inhibition of the enzyme CYP17, which blocks the synthesis of testosterone; and androgen receptor antagonism, which blocks the binding of testosterone or DHT (dihydrotestoterone) with the androgen receptor. Tokai Pharmaceuticals, the manufacturer of Galeterone, has started to enroll US patients into a randomized Phase III clinical trial of treatment with Galeterone. Patients will be randomized to treatment with either Galeterone or Enzalutamide. There will be Australian study locations commencing shortly. Click for more information.
  12. We've previously mentioned what an excellent resource the australianclinicaltrials.gov.au website is if you want to find out information about clinical trials. It has information about: What is a Clinical Trial? Why be part of a Clinical Trial? How to be part of a Clinical Trial? How to find a Clinical Trial? A new section called "Real Stories" with videos from participants in clinical trials has just been added. One of those "Real Stories" is a video about our Committee Member, Tony Maxwell.
  13. We are all familiar with the concept of intermittent ADT as opposed to continuous ADT. Now researchers are investigating the concept of intermittent chemotherapy as opposed to continuous chemotherapy. If certain criteria are met, there will a break in the chemotherapy treatment and the patient will have a “drug holiday”. In theory intermittent chemotherapy may serve 2 purposes. First, with less constant exposure to the drug, this may potentially delay the development of taxane-refractory disease. Second, breaks in therapy or “drug holidays” may improve the quality of life for patients, allowing them to recover from the cumulative toxicity of chemotherapy during these “drug holidays.” Resolution of drug side effects may also allow taxane therapy to be prolonged, which could also improve outcomes. It is interesting to see that one of the abstracts for the 2016 ASCO (American Society of Clinical Oncologists) meeting in Chicago next week is about “PRINCE: A phase III study comparing intermittent docetaxel therapy versus continuous docetaxel therapy in patients with castration-resistant prostate cancer”. PRINCE which was a study conducted by German researchers found that: “The intermittent docetaxel chemotherapy was non-inferior to a continuous therapy in one-year survival. It was well tolerated and may present a treatment option for patients with CRPC”. Reference: http://abstract.asco.org/176/AbstView_176_170886.html
  14. Sam Poley's father had aggressive and advanced prostate cancer. About a year ago Sam started a crowdfunding campaign to raise at least $1 million to fund a Phase II clinical trial to investigate the feasibility of using an FDA-approved and generally well-tolerated drug called disulfiram in the treatment of castration-resistant prostate cancer. Prostate Cancer needs copper—in fact, it’s a glutton for copper and will consume all it can get. This clinical trial will be designed to exploit that as a weakness Unfortunately Sam's dad has died but the appeal has raised $460,000 so far. This is enough to start the trial with 30 patients and more patients will be admitted as the campaign continues to pursue its $1 million target. Click on this link to read an article about the campaign in the New Prostate Cancer Infolink or on this link to read the Give 1 for Dad website. May be some of us will benefit from this research.
  15. 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.
  16. Paul Edwards

    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.
  17. When should I consider a clinical trial? This 6 minute YouTube video answers this question. The doctors are from the MD Anderson Cancer Centre in the USA, but your Australian medical oncologist will also have access to many clinical trials. https://www.youtube.com/watch?v=sedcDN1JBWs
  18. Paul Edwards

    "Bipolar Androgen Therapy"

    In a surprising paradox, the male hormone testosterone, generally thought to be a feeder of prostate cancer, has been found to suppress some advanced prostate cancers and also may reverse resistance to testosterone-blocking drugs used to treat prostate cancer. A small study of 16 patients at the Johns Hopkins Kimmel Cancer Center was reported in the Jan. 7 issue of Science Translational Medicine. Larger studies are necessary before the treatment can be used outside clinical trials. Here is a link to a report in the HealthDay newsletter about the study: http://consumer.healthday.com/cancer-information-5/prostate-cancer-news-106/strategy-might-thwart-resistance-to-a-common-prostate-cancer-treatment-695278.html
  19. Paul Edwards

    New Ipilimumab Trial in Australia

    Ipilimumab (brand name Yervoy) is an immunotherapy approach to the treatment of cancer. Ipilimumab was the first treatment ever proven to extend survival in patients with metastatic melanoma, the deadliest form of skin cancer, and has been approved by the Australian Pharmaceutical Benefits Scheme for that treatment. Ipilimumab was tested in two phase III trials as a treatment for advanced, castration-resistant prostate cancer. In the patients receiving Ipilimumab after docetaxel, the drug failed to improve overall survival. Results of the trial in which patients received Ipilimumab prior to chemotherapy are not yet available. Ipilimumab is also now being tested in several phase II trials. One of these trials is a “Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive”. Details of this trial are available at the ClinicalTrials.gov site Identifier: NCT02279862. The trial is being conducted at 6 Australian locations in Melbourne, Sydney and Perth. One of the Melbourne locations has commenced recruitment.
  20. Unlike many who have posted their stories in this forum, my journey has only just started. I was diagnosed with prostate cancer in 2012 at age 64. On 15 June 2012 I had a PSA test which returned a result of 28.1. On 12 July 2012 a further PSA test returned a result of 30.1. I then had a biopsy which revealed Gleason 9 cancer. Imaging showed metastasis to the pubic bone. Because the cancer had metastasised, in accordance with current practice, localised treatment of the prostate was not considered as an option by my urologist. I was then placed on Hormone Therapy - initially on Cyprohexal for a short period for flare and then on Eligard. I remained on Eligard injections until mid October 2013 when Firmagon was substituted for Eligard. I am still on Firmagon. Casodex was added at the start of September 2013. In December 2012 I changed my primary medical practitioner from my original urologist to Dr Ben Tran, an excellent medical oncologist. My wife describes Ben as “her favourite doctor”. Most doctors regard prostate cancer as either confined to the prostate gland and curable, or widely metastatic and incurable. In recent years it has been suggested that there is an intermediate stage (oligometastatic) where the cancer has spread outside the prostate gland but is not widespread. In 2004 a study by the University of Rochester in New York documented in detail the existence of oligometastatic disease in prostate cancer metastatic to bone. An appreciable proportion of those with five or fewer lesions remained stable for up to several years before the cancer started to spread widely. Those with more than five bone lesions were much more likely to spread widely. The authors proposed that stereotactic radiation to bone metastases in those with five or fewer may eliminate the bone metastatic cancer and make the patients disease-free for a prolonged period of time. Stereotactic radiation is delivered as a single, high dose, precision treatment which is a radical departure from conventional palliative radiotherapy which is delivered daily for several weeks. Most importantly, stereotactic radiation is potentially curative compared to conventional radiotherapy to such tumours. Ben Tran referred me to Dr Farshad Foroudi, a radiological oncologist at Peter MacCallum Cancer Hospital in Melbourne who is conducting A Pilot study of patients with Oligometastases from Prostate cancer treated with STereotactic Ablative body Radiosurgery (POPSTAR) on patients who had 3 or less metastases. While stereotactic radiation has been used in other cancers as well as for prostate cancer confined to the prostate, this trial is one of the first in patients whose prostate cancer has spread. After scans, it was determined that I would be eligible for the clinical trial but only if I had my prostate treated. Due to the proximity of the metastasis on the pubic bone, treatment of the prostate by radiation was not possible. This meant that surgery was the only way to treat the prostate. I then met with a surgeon, Mr Daniel Moon, to discuss possible surgery. Both Ben Tran and Daniel Moon warned that a radical prostatectomy involved serious potential side effects without any evidence in clinical trials of benefit, albeit that some data suggested favourable results. However, I decided to proceed with the surgery. On Daniel Moon’s recommendation, prior to the surgery I had a number of appointments with a physiotherapist specialising in continence management. [Clinical trials have shown that pre‑operative pelvic floor muscle training improves the recovery of continence after a radical prostatectomy]. On 14 June 2013 I had a robotic laparoscopic radical prostatectomy at Epworth Hospital. Post surgery my catheter remained in for a month; the slower than normal internal healing was probably caused by the fact that my prostate had been very enlarged (130cc). Apart from the delayed removal of the catheter, the operation was a success and I recovered continence almost immediately after the catheter was removed. I cannot speak too highly of the skill and care of Daniel Moon. My PSA, 4.2 before the prostatectomy, was 0.7 in mid July 2013 but then started to rise again. Until the imaging that I received for the POPSTAR trial, I believed that I only had a single metastasis. Apparently my initial scans had also showed metastasis to a lymph node but I was not advised of this. The POPSTAR scans confirmed a lymph node metastasis. On 26 September 2013 and 1 October 2013, following several planning sessions, I received stereotactic body radiation treatment; one session for the lymph node metastasis and one for the pubic bone metastasis. The treatment was very quick and easy and free from side-effects. It can take up to 18 months for cancer cells to die following radiation. As part of the clinical trial, monitoring continues over a 2 year period. I have recently had my 3 month follow-up visit. At the 6 month follow-up visit I will have a further PET scan to examine the impact of the radiation on the tumours. My PSA is now 0.066, down from 1.00 prior to the radiation treatment, and likely to still be falling. All of the cancer sites revealed by imaging have now been treated. Even though it is highly likely that I have in my system micro-metastatic disease which is not detectable by current imaging technologies, I believe that it can only be beneficial to have significantly reduced the cancer load in my system. It’s now a matter of watch and wait. I’m very grateful for the information and support that I have gained from this forum and the monthly teleconference, particularly the suggestions about the role of the different specialists in your medical treatment. I’ve been extremely fortunate with my medical team. All of them are extremely talented, are excellent communicators, are readily accessible between scheduled appointments (by email and phone) and have a collaborative approach. Dr Emily Gianatti, Endocrinologist has recently been added to the team. At times when asking questions of my very long-suffering doctors, I’m surprised that I haven’t received the type of response that Jerome K Jerome got from his doctor (See Chapter 1 of “Three Men in a Boat” at http://www.authorama.com/three-men-in-a-boat-1.html ) [uPDATED 13 May 2014] So much for no side effects from my Stereotactic radiation! About 5 months after my Stereotactic radiation I experienced pain in my groin which was similar to that experienced before my first bone metastasis was diagnosed. 6 months after my Stereotactic radiation I had a F-18 fluoride scan as part of the clinical trial. There was persisting radiotracer uptake at the site of radiation on my pubic bone. This potentially reflected ongoing skeletal repair at the site of radiation, rather than active cancer. It was recommended that the radiation site be monitored in the future with further imaging. There was no indication of new metastatic disease. I then had a C/T Scan which indicated that the lymph nodes that had been radiated had shrunk significantly in size and were now difficult to measure. An MRI has now identified inflammation of the muscles adjacent to the pubic bone, most likely caused by the radiation treatment. This inflammation is now being treated. [uPDATED 8 July 2014] I've just had my 9 month review appointment at Peter MacCallum Cancer Centre following my Stereotactic radiation. I was told that I was the only patient at Peter Mac who had experienced muscle inflammation from Stereotactic radiation (all patients not just PCa patients). I replied that this information was not much comfort to me. The groin is still a bit niggly but it's getting better. I've just done 3 consecutive days in the gym without too much pain. My next appointment at Peter Mac is in 3 month's time when they'll do another lot of bone scans. Just had my 6 monthly review with the endocrinologist. Vitamin D which has been persistently low despite supplementation is now where it should be. Cholesterol is higher than I'd like. Probably this is a result of the groin problems preventing from me doing much exercise. Had a good chat to her about the difference between DEXA and QCT scans for bone density. [uPDATED 16 October 2014] On 30 July 2014 I had an appointment with my medical oncologist. At my request he changed my hormone treatment from monthly Firmagon injections to three monthly Zoladex injections (After 9 months of Firmagon injections I’d had enough of the injection site pain). We discussed whether to stop Casodex but decided to keep going with it at this stage. I discussed with him Snuffy Myers’s comments regarding Metformin. He was happy to prescribe this, subject to my endocrinologist managing the endocrine effects. After discussing the effect of Dihydrotestosterone (DHT) he also added Avodart to my medication. At the start of October 2014 I had Bone and C/T Scans at Peter MacCallum Cancer Centre as part of my 12 month post treatment review. The scans showed things going in the right direction- the 2 sites that had been treated appeared to be free of cancer and there was no new cancer elsewhere. However, the PSA tests were going in the wrong direction – from a nadir of 0.117 in July, it had risen to 0.45. In mid October my medical oncologist requested a PET Scan for me, a PSMA one with the new Gallium68.tracer. He dropped Casodex from my medication. [uPDATED 2 February 2015] At the end of November 2014 I had a PSMA PET Scan which showed up active sites that were not shown on previous imaging: 1 in the left internal iliac node and 2 in the small bilateral posterior iliac bones. Each of these sites is technically treatable with stereotactic radiation but there may be no practical benefit in doing so. Because stereotactic radiation is a relatively new treatment, the radiology oncologists do not know whether treating these sites will delay the progression of my cancer. My case was referred to the multidisciplinary committee for discussion. The multidisciplinary committee decided that treating the new metastases with stereotactic radiation was a reasonable approach. Early in January 2015 I had the set up session for the stereotactic radiation. On 30 January 2015 and 2 February 2015 I had stereotactic radiation on these 3 sites. My PSA before the treatment was 0.89. The PSMA PET Scan also showed a possible recurrence in the prostate bed near the urethra. Sometimes urethras can display PSMA uptake if there is a hold up or pooling of urine which often happens after surgery. If it is a local recurrence, the area is too close to the urethra to use radiation. [uPDATED 26 June 2015] An MRI in May 2015 confirmed that the suspect lesion shown in the PSMA Pet Scan was an actual lesion and showed a new bone met that was not present in the PSMA PET Scan. The Radiology Oncologist said that, whilst the stereotactic radiation had been successful in killing the "weeds" that had grown, it was not stopping more "weeds" from seeding and that systematic treatment was needed now. That's the end of my radiation treatment for the moment so back to the medical oncologist. As I've mentioned in other posts on the forum, I don't think that my disease was truly oligometastatic. [uPDATED 16 October 2015] My oncologist sent me off for bone and CT scans for restaging purposes. At the end of July my PSA was 3.8. Bone Scan shows limited metastatic disease in pelvis and the sternum. My medical oncologist suggested that the systemic treatment should be a clinical trial being run by Jansen or, if not eligible for that trial, chemotherapy. I was unable to complete the trial prerequisites before our overseas holiday In September. From a treatment viewpoint it probably would have been better for cancel the holiday. However we hadn’t had a decent holiday for a while so decided not to cancel the holiday. In early October as soon as we returned from overseas I had further bone and CT scans as part of the assessment for the clinical trial. My PSA had gone up to 16.4. The scans showed that there had been substantial progression in the last 2 months with mets having spread to ribs and spine. On 14 October when I commenced the clinical trial, my PSA was 19.4. The trial is “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 ”( ClinicalTrials.gov Identifier NCT02257736). JNJ-56021927 (formerly called ARN-509) is a drug with a similar action to Enzalutamide. Whichever arm of the trial I am in, I receive Abiraterone Acetate. [Updated 25 June 2016] Within a few days of starting the trial, any bone pain that I had went away. In my first month my PSA dropped by more than 50% (If PSA does not drop more than 50% in the first month, this can be a sign that Abiraterone will not work: http://www.medscape.com/viewarticle/827466_4 ) The only side effect was increased fatigue. My PSA continued to drop for 5 months then started to increase. To fail the trial, the researchers look at 3 things: PSA Progression, Pain Progression and Progression evident from Scans. By the time of my monthly clinical trial tests in June, I had achieved the trifecta. So only 9 months on Abiraterone, rather than the median of 17 months. Bugger! - why am I at the wrong end of the bell curve? What next? Probably chemo. To be continued.
  21. 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.
  22. Doctors have been starting to use the newer drugs such as Xtandi (enzalutamide) and Zytiga (abiraterone) before docetaxel. This has moved chemotherapy further back in the sequence of treatment. Now there is evidence for a role for earlier chemotherapy for some men. By moving docetaxel from the castration-resistant stage, when men were not responding to testosterone-lowering agents, to the castration-sensitive state, when they were, the survival benefits were amplified. The evidence comes from a clinical trial, “Chemohormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED)”. The results were presented at the 2014 annual general meeting of the American Society of Clinical Oncology (ASCO). The trial compared “upfront” docetaxel plus hormone therapy with hormone therapy alone in men with metastatic prostate cancer. When patients enrolled in the trial, they were classified by the extent of their metastatic disease as high-volume or low-volume. High volume was defined as visceral metastasis or 4+ bone metastases or both. In men with high volume metastatic prostate cancer, the trial found that docetaxel plus hormone therapy improved survival over hormone therapy alone. Longer follow-up was needed for men with low volume metastatic prostate cancer. Dr Christopher Sweeney, the lead investigator of the trial, said: “This is one of the biggest improvements in survival we have seen in a trial involving patients with an adult metastatic solid tumour.” Dr Michael J. Morris of Memorial Sloan Kettering Cancer Centre commented: “The best therapies reported previously have less than a third of the benefit seen in these patients.” This study will not change the sequence of treatment for all patients. This treatment applies only to men who had high volume metastatic cancer when first diagnosed. Only about 4% of men with prostate cancer have metastatic cancer when first diagnosed. Of that 4% the number of men with high-volume disease is even smaller. Also to receive this treatment, patients must be well enough to receive docetaxel therapy. Dr Sweeney is now involved in a clinical trial looking at the “upfront” treatment of newly diagnosed prostate cancer patients with docetaxel plus hormone therapy plus Xtandi (enzalutamide). There are 2 talks on the internet about “upfront” docetaxel plus hormone therapy. One is by Dr Snuffy Myers on his blog. This talk is designed for patients with prostate cancer. Here is the link to the video by Dr Myers: http://askdrmyers.wordpress.com/2014/06/05/taxotere-lupron-before-adt/ The second is an interview on the Uro Today website with Dr Sweeney. This interview is intended for urologists. It is not suitable for general listeners. Unless you have a detailed knowledge of clinical trials and of the statistical methods used in these trials, you should not listen to this interview. Further information about the CHAARTED trial (including a link to the abstract of the trial) is available on the ASCO website.
  23. Paul Edwards

    Another setback for TAK-700

    Orteronel (TAK-700) is an androgen synthesis inhibitor. It selectively inhibits the enzyme CYP17A1.. A paper presented yesterday at the American Society for Clinical Oncology (ASCO) meeting reported the results of a second large Phase III clinical trial of Orteronel + Prednisone in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer. In the trial, whilst treatment with Orteronel + Prednisone was shown to delay the onset of radiographic progression, there was no overall survival benefit. Orteronel + Prednisone was also associated with a number of significant side effects compared to placebo + prednisone; 30% of patients on the Orteronel + Prednisone arm of the trial discontinued due to adverse side effects. A previous Phase III clinical trial of Ortoronel + Prednisone for the treatment of men with progressive, metastatic, castration-resistant prostate cancer who had been previously treated with at least one cycle of docetaxel-based chemotherapy also showed no overall survival benefit. The New Prostate Cancer Infolink commented: "This is clearly a second major setback for the potential of Orteronel as a potential treatment for prostate cancer, and it is hard to see that the developers will pursue the potential of this product for much longer.” Given that other drugs recently approved by the American Food and Drug Administration (FDA) such as Zytiga and Xtandi have demonstrated an overall survival benefit, it is unlikely that Orteronel would receive FDA approval on the current evidence.
  24. 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.
  25. The Prostate Cancer Foundation has advised us that the following clinical trial being conducted at Deakin University, 221 Burwood Highway, Burwood, Melbourne is now recruiting. The efficacy of exercise training and nutritional supplementation in prostate cancer survivorsTrial Summary: The aim of this study is to evaluate the efficacy of resistance exercise training and nutritional supplementation in prostate cancer survivors treated with androgen deprivation therapy. Who is it for? You may be eligible to join this study if you are a male aged 50-85 years and are currently undergoing treatment for prostate cancer with androgen deprivation therapy which is expected to continue for at least 52 weeks. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an individually tailored progressive resistance exercise training program three times a week and receive daily supplementation of calcium, vitamin D and protein over a period of 52 weeks. Participants in the other group will receive the usual care administered to men undergoing androgen deprivation therapy. Participants will be assessed at baseline, 26 weeks and 52 weeks in order to determine any changes in musculoskeletal health, cardiometabolic risk factors, and health-related quality of life. Assessment is by bone scans, blood tests, and questionnaires. The results of this study may contribute to the development of exercise and nutritional guidelines for optimising overall health in men treated with androgen deprivation therapy. If you are interested in participating or would like further information, please contact Patrick Owen email pow@deakin.edu.au or phone: 03 9244 5013 or mobile:0414 221 902.
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