Prostate
The following list provides a brief description of prostate cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.
Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.
Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.
10TASQ10 Study
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Registered Title |
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer. |
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Purpose |
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
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Acknowledgements: US National Library of Medicine
Abiraterone Early Access Program (EAP)
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Registered Title |
An Open-label Study of Abiraterone in Subjects with Metastatic Castration-Resistant Prostatic Cancer who have Progressed after Taxane-based Chemotherapy. |
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Purpose |
The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC). |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God
SCGH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
CBCT - Image Guided Radiation Therapy
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Registered Title |
Cone Beam Computed Tomography: The future of image guided RT. |
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Purpose |
To evaluate conventional electronic portal imaging using Cone Beam Computed Tomography (CBCT) sectional images as the benchmark.
To evaluate Cone beam CT for its usefulness and accuracy for identifying the prostate gland in planning.
To implement a pilot study of a novel imaging technique Limited-angle cone-beam digital tomosynthesis (LA-CBDT) and quantify the efficacy of the technique.
To perform a detailed cost-benefit analysis of practicable Image guided radiation treatment modalities. |
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Lay Summary |
This study is for men who need radiation therapy for prostate cancer. It will investigate using advanced prostate localisation x-ray imaging to make sure the radiation beams are on the target every day. This imaging is called Cone Beam Computed Tomography or CBCT.
CBCT is similar to CAT scan. It provides three-dimensional images of the treatment target volume while you are on the treatment machine and lying in the treatment position.
Phase 1 of the study will recruit 25 consenting patients who will be treated with the usual 7 week course of radiation using conventional Electronic portal imaging. Weekly CBCT investigations will be done and this will incur an additional exposure to low energy x-radiation. This additional dose is 0.2% of the prescribed therapeutic dose of 74 Gy.
Phase 2 and 3 will be done concurrently, with the aim to recruit 50 patients. Patients will have 3 small gold markers permanently implanted into the prostate gland. This procedure will be done by the urologist prior to commencing radiation therapy. The radiation remains 7 weeks of treatment as is standard for all prostate patients. For phase 2 there will be additional CBCT scans which will incur an additional exposure to low energy radiation. This equates to 0.4 % of your prescribed radiation dose. |
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WA Trial Sites |
Perth Radiation Oncology Centre |
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Links |
FIRSTANA (EFC11784)
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Registered Title |
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy. |
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Purpose |
To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
Acknowledgements: US National Library of Medicine
Image Guided Radiation Therapy
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Registered Title |
Image guided Radiation Therapy for Prostate Cancer. |
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Purpose |
Image guided radiation therapy (IGRT) is a new method of using advanced imaging technology to accurately image and track the movement of your prostate cancer during the course of your radiotherapy treatment. |
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Lay Summary |
Accurate tracking of the prostate cancer is essential to resolve daily prostate location changes due to normal organ motion and body position variation on the treatment couch.
IGRT will ensure high dose radiotherapy can be precisely delivered to the prostate cancer while limiting the dose to normal surrounding sensitive tissues like rectum and bladder.
To assist with Image guided radiation therapy (IGRT), three gold markers are inserted into the prostate gland to serve as reference landmarks for your prostate location and to guide the accurate delivery of radiation therapy to your prostate cancer.
Gold marker insertion requires patient consent. It also requires taking a course of antibiotics, starting prior to the radiation treatment.
Bowel preparation is also important prior to gold marker insertion. |
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WA Trial Sites |
Perth Radiation Oncology Centre |
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Links |
N/A |
IPILIMUMAB 095 - Asymptomatic
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Registered Title |
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer. |
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Purpose |
The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
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Acknowledgements: US National Library of Medicine
IPILIMUMAB 043 - Post Treatment
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Registered Title |
Randomized, Double-Blind, Phase III Trial Comparing Ipilimumab vs Placebo Following one dose of Radiotherapy in Subjects with Castration Resistant Prostate Cancer (CRPC) that have Received Prior Treatment with Docetaxel |
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Purpose |
The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
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Acknowledgements: US National Library of Medicine
Millennium C21004
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Registered Title |
A Phase 3 Randomised Double-blind Multicenter trial Comparing Orteronel (TAK-700) plus Prednisone with Placebo plus Prednisone I Patients with Chemotherapy-naïve Metastatic Castratin-Resistant Prostatic Cancer. |
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Purpose |
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). |
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Lay Summary |
N/A |
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WA Trial Sites |
SCGH Medical Oncology
RPH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
Millennium C21005
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Registered Title |
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy. |
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Purpose |
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following taxane-based therapy. |
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Lay Summary |
N/A |
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WA Trial Sites |
SCGH Medical Oncology
RPH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
ProCare Trial
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Registered Title |
A Phase II randomised controlled trial of follow up of men with prostate cancer in primary care, to assess the acceptability and feasiblity of a shared care model. |
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Purpose |
To develop and test a shared care model of 12 month follow up (between hospital and GPs) for men treated for prostate cancer and that aims to reduce psychological distress and unmet psychosocial and psychosexual needs. |
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Lay Summary |
The study hypothesis is that a shared care model of follow-up for prostate cancer is feasible, and demonstrates the potential to reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care, at lower cost compared to usual care. |
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WA Trial Sites |
Fremantle Hospital |
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Links |
PROSELICA (EFC11785)
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Registered Title |
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen. |
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Purpose |
To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
Acknowledgements: US National Library of Medicine
RAVES
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Registered Title |
A phase III multi-centre randomised trial comparing adjuvant radiotherapy (RT) with early salvage RT in patients with positive margins or extraprostatic disease following radical prostatectomy. |
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Purpose |
To see which of two ways of managing men with high risk features is better in controlling PSA in the long term.
To see how treatment and illness affect quality of life and feelings (mood). |
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Lay Summary |
This study is for men who have had surgery to remove prostate cancer and the features of the cancer (as determined by a pathologist after the surgery) indicate the risk of the PSA rising again may be higher than other patients. There are currently two ways to manage these men:
Immediate radiotherapy - which is a course of radiotherapy to the area where the prostate gland used to be. The radiotherapy is given over about 6 and a half weeks (5 times a week). It is now known from several large studies that giving radiotherapy to everyone immediately after surgery will halve the risk of the PSA rising again. This means that only half of the men who have radiotherapy benefit from it. Unfortunately we don't know which men benefit from radiotherapy and which don't. It would be simple to give everyone radiotherapy if there were no side effects but many men experience unpleasant side effects.
The second way to manage these men is to watch them very closely ("active surveillance") with regular clinic visits and regular PSA blood tests. The PSA blood test can detect activity of the cancer months or years before other tests and usually long before any symptoms appear. Radiotherapy is only given if the PSA starts to rise. In this situation nearly half the patients would be spared the possible side effects of radiotherapy.
It is not known whether these 2 ways of managing men with high risk features are the same in controlling the PSA long term. The aim of the study is to therefore see whether patients treated with active surveillance (and giving radiotherapy as soon as the PSA rises) is as good as immediate radiotherapy. This study will also compare the side effects occurring in each treatment group and what affect the treatments have on quality of life. It will also compare whether the 2 ways of managing men with high risk features results in the same percentage of men who are alive and without prostate cancer. |
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WA Trial Sites |
Perth Radiation Oncology Centre Royal Perth Hospital
SCGH Radiation Oncology Fremantle Hospital |
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Links |
Taxotere 2006-128 Study
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Registered Title |
Docetaxel (Taxotere®) plus 6-Month Androgen Suppression and Radiation Therapy vs. 6-Month Androgen Suppression and Radiation Therapy for Patients with High-Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial. |
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Purpose |
In this study, we will compare the effectiveness of the combination of docetaxel plus standard therapy to standard therapy without docetaxel in treating this stage of prostate cancer. |
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Lay Summary |
Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere) will make this treatment more effective. Docetaxel is a Therapeutics Goods Administration (TGA) approved drug for treating prostate cancer, but it has not been TGA approved for treating this stage of prostate cancer. It is not clear, at this present time, if there is a benefit of using docetaxel (Taxotere) in addition to the current standard treatment for this stage of the disease. |
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WA Trial Sites |
SCGH Radiation Oncology |
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Links |
TROG 03.04 BE PREPARED Study (A sub-study of RADAR)
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Registered Title |
Bone metastasis Evolution: Prospective Evaluation of P1NP and CgA/NSE Measures to Assess Bony Relapse of Prostate Cancer Early in its Development (Be-Prepared). |
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Purpose |
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Lay Summary |
Evidence suggests that advanced prostate cancer commonly spreads into the bones. It is important to diagnose the spread of cancer into the bones early, so that treatment can start as soon as possible. One purpose of the Be-Prepared study is to test new methods for identifying spread of cancer outside the prostate (metastasis). Another purpose is to see if patients can be offered more options in terms of treatment for their prostate cancer.
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WA Trial Sites |
SCGH Radiation Oncology |
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Links |
N/A |
TROG 03.06 (TOAD Study)
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Registered Title |
A collaborative randomised phase III trial: The Timing Of intervention with Androgen Deprivation in prostate cancer patients with a rising PSA (TOAD). |
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Purpose |
To compare Delayed (watch and wait) versus Immediate Androgen Deprivation Treatment (ADT) in men diagnosed with prostate cancer and presenting with biochemical (PSA) relapse, including men who are Post treatment (surgery and/or radiotherapy) + hormone treatment and men who have had NO prior treatment and NO symptoms. With the objective to evaluate survival and quality of life in men who receive immediate treatment compared to delayed treatment, and also between the post-treatment and no treatment groups. |
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Lay Summary |
One school of thought is that PSA (Prostate Specific Antigen) can detect prostate cancer activity months or years before any symptoms appear. Therefore, testing for PSA has allowed clinicians to monitor the progress of prostate cancer. Research claims removing the male hormone testosterone usually causes the PSA level in men to fall. Although not a cure, this is helpful in controlling the disease. Androgen Deprivation Therapy (ADT) is a way to remove the male hormone testosterone and is one way to control the disease, even in men who have no other signs of active cancer. However, ADT can cause side effects and thus the usual approach is to delay treatment until there are signs of disease progression.
This research is a randomised control trial and this means that when patients are deemed eligible for the trial, they will be randomly allocated to either start ADT as soon as possible (within 8 weeks of randomisation), or delayed ADT. That is watch and wait for a period of time (usually at least a year) until the PSA has been shown to rise further or faster, or symptoms develop. |
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WA Trial Sites |
SCGH Radiation Oncology Fremantle Hospital |
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Links |
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