Clinical Trials
For a list of ongoing prostate cancer clinical trials in Australia, please visit:
www.anzctr.org.au and www.cancertrialsaustralia.com/Clinical-Trials-Register.aspx
New treatments for prostate cancer are continually being developed. The focus is particularly on new treatments for cancer that it is no longer responding to Androgen deprivation therapy.
Chapter 9 of the newly launched and readily available free of charge book, “Advanced Prostate Cancer, a guide for men and their families” contains detailed information about the specific steps a new treatment must go through in order to be given the green light to be tested in humans. At the Prostate Cancer Foundation of Australia we will do whatever possible to inform you about the new clinical trials that are available in an area near you. However, here are some recommended questions you may want to ask when considering a clinical trial (1):
- Which treatments are being tested and why?
- What are the benefits to me or to others?
- What extra tests apart from my normal treatment will I be involved in?
- What are the possible risks or side effects?
- How long will the trial last?
- Will I need to go to hospital for treatment?
- What will I do if any problem occurs while I am in the trial?
- Can the trial affect my options for future treatment?
- Can I withdraw from the trial if I change my mind?
- Can I be on more than one trial at a time?
(1) “Advanced Prostate Cancer, a guide for men and their families”, APCC, 2009
BMS Study
BMS CA184-043: A phase 3 trial comparing ipilimumab vs. placebo following radiotherapy in patients with castrate-resistant prostate cancer (CRPC) that have received prior treatment with docetaxel:
Bristol-Myers Squibb (BMS) is conducting a Phase 3 trial using a novel immunotherapy agent in patients with metastatic CRPC that have received prior treatment with docetaxel. Ipilimumab (anti CTLA-4 monoclonal antibody) plus radiotherapy will be compared to placebo plus radiotherapy in this randomized, double-blind study, to determine if ipilimumab prolongs survival in men who have metastatic CRPC.
This study, which is currently recruiting patients, will be conducted at 5 sites in Australia and in 24 other countries around the world. The study is listed on the US. federal clinical trials website: www.clinicaltrials.gov under CT Identifier NCT00861614.
Some of the main eligibility criteria for the study are as follows: (Note: not all criteria are listed)
Inclusion Criteria:
- Male, 18 years or older
- Advanced prostate cancer
- At least 1 bone metastasis
- Testosterone < 50 ng/dl
- Prior treatment with docetaxel
Exclusion Criteria:
- Brain metastasis
- Autoimmune disease
- Known HIV, Hepatitis B, or Hepatitis C infection
- More than 2 prior systemic anticancer regimens for prostate cancer
If you are interested in finding out more information regarding this study and to discuss if you may be eligible, please contact your treating doctor who can find out more information or contact the site closest to you (listed below) which is directly involved in the study. If you live a distance from all study sites but are still interested, we suggest you still contact your treating doctor or closest study site for initial discussions.
Study Site |
Site Contact(s) |
Contact Information |
Peninsula Oncology Centre, Frankston, VIC |
Mr Albert Goikhman (Study coordinator) |
(03) 9771 8909 |
Box Hill Hospital, Box Hill, VIC |
Ms Suzanne Giddins (Study coordinator) |
(03) 9095 2463 |
Canberra Hospital, Canberra, ACT |
Dr David Leong (Investigator) A/Professor Paul Craft (Investigator) |
(02) 6282 4831 (02) 6244 2220 |
St John Of God, Subiaco, WA |
Dr Joanne Youd (Study coordinator) |
(08) 6465 9204 |
Austin Hospital, VIC |
Ms Rosemary Hoyt (Study coordinator) |
(03) 9496 3038 |
The study has been approved by the appropriate HRECs in Australia as applicable.
Men with castration resistant prostate cancer in Australia may be eligible for a new trial that has recently begun recruiting. The trial, ALSYMPCA, is an international phase III clinical study to evaluate the safety and efficacy of 'Alpharadin', in patients with hormone refractory prostate cancer (HRPC) and skeletal metastases. The study will measure the impact on survival of 'Alpharadin' in over 700 patients across 20 countries.
'Alpharadin' is a first-in-class, alpha-emitting pharmaceutical (AEP) and a highly targeted treatment for patients with bone metastases (Ref: Nilsson et al, The Lancet Oncology, July 2007; 8:7, 587-594. Bruland et al, Current Radiopharmaceuticals; 2008: 1: 203-208)
ALSYMPCA is already listed on www.clinicaltrials.gov and has recently been added to other clinical trial search websites such as www.anzctr.org, www.studien.de in Germany, www.cancer.org.uk in the UK and www.cancerworld.org.
We are keen to ensure that eligible patients in Australia who would like to be considered for the trial do not miss out on recruitment.
As background to the trial, attached is the summary as used or the US website – www.clinicaltrials.gov – as well as a list of the trial centres involved in the study. As background to 'Alpharadin' itself, I attach a link to a recent article in 'Lancet Oncology'.
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70147-X/abstract
We suggest that patients who wish to be considered f
a) ask their GP to contact the hospital closest to them, which is involved in the trial to discuss their suitability for this trial. Patients should please go to www.algeta.com to see a list of the hospitals. Should their GP need further information on the study, the following can be contacted: Bjorg Bolstad or Gillies O'Bryan-Tear at Algeta (+47 23 00 79 90) or by emailing alpharadin@algeta.com).
or :
b) ask their oncologist to contact the hospital closest to them, which is involved in the trial.
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13
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16-200 |
Dr David Dalley |
St Vincent's Hospital, Sydney |
16-201 |
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Sir Charles Gairdner Hospital , Perth |
16-202 |
Dr Martin Berry |
Liverpool Hospital , Sydney |
16-203 |
Prof Michael Brown |
Royal Adelaide Hospital , Adelaide |
16-204 |
Dr Henry Woo |
Sydney Adventist Hospital , Sydney |
16-205 |
Dr. Anthony Dowling |
St Vincent's Hospital, Melbourne |
16-206 |
Dr. Graeme Dickie |
Royal Brisbane and Women's Hospital, Brisbane |
16-207 |
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Prince of Wales Hospital , Sydney |
16-208 |
Dr. Rosemary Harrup |
Royal Hobart Hospital
,
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16-209 |
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Queen Elisabeth Hospital , Adelaide |
16-212 |
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Toowomba Cancer Research Centre,
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16-213 |
Dr Gavin Marx |
Shore Hospital , St Leonards, NSW |
16-214 |
Dr Kerwyn Foo |
Illawarra Cancer Group, Wollongong Hospital, NSW |
MOTIF Clinical Trial Study
Men with metastatic prostate cancer who are being treated with Taxotere chemotherapy in Australia may be eligible for a clinical trial. The trial is called MOTIF and is looking to see if adding a drug called modafinil to standard prostate cancer chemotherapy can help patients with fatigue and quality of life during their treatment. If you are currently undergoing treatment with Taxotere on a three weekly cycle and have experienced some symptoms of fatigue (tiredness, lack of energy etc) then you could be eligible for the MOTIF study. Taxotere is a standard treatment for patients with metastatic prostate cancer and a common side effect experienced by patients taking this drug is fatigue. Modafinil is a wakefulness-promoting agent that may be a potentially effective treatment for the fatigue associated with this cancer chemotherapy. The MOTIF study lasts up to 15 weeks and includes up to 6 hospital visits, the study is a placebo controlled study which means there is a approximately 50% chance that you will receive modafinil. We want to ensure that eligible Australian patients do not miss on out recruitment and would encourage patients who would like to be considered for inclusion in the MOTIF study to contact the hospital closest to them that is involved in the trial – see site details below.