Clinical Trials


For a list of ongoing prostate cancer clinical trials in Australia, please visit:

Australian and New Zealand Urogenital and Prostate Cancer Trials Group - www.anzup.org.au
Australian Clinical Trials Online - www.australiancancertrials.gov.au
Australian New Zealand Clinical Trials Registry - www.anzctr.org.au
Cancer Trials Australia - www.cancertrialsaustralia.com
Clinical Trials - www.clinicaltrials.gov
Cancer Trials Sydney Western Area Health Service - www.cancertrials.com.au
Cancer Institute NSW - www.cancerinstitute.org.au/cancer_inst/research/
National Cancer Institute - www.cancer.gov/search/clinical_trials
Cancer Council WA - www.cancerwa.asn.au/patients/
Cancer Council VIC - www.cancervic.org.au/trials/

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.

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 or inclusion in the ALSYMPCA trial, should either:

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.


 

 

 

16-200

Dr David Dalley

St Vincent's Hospital, Sydney

16-201

 

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

 

Prince of Wales Hospital , Sydney

16-208

Dr. Rosemary Harrup

Royal Hobart Hospital , Tasmania

16-209

 

Queen Elisabeth Hospital , Adelaide

16-212

 

Toowomba Cancer Research Centre, Queensland

16-213

Dr Gavin Marx

Shore Hospital , St Leonards, NSW

16-214

Dr Kerwyn Foo

Illawarra Cancer Group, Wollongong Hospital, NSW


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