This site is now managed by the Commonwealth Department of Health and Aged Care.
Broad Health Condition Cancer
Specific Health ConditionProstate
Hollywood Private Hospital - Nedlands
6009 - Nedlands
Anticipated date of first participant enrolment3/06/2019
Anticipated date of last participant enrolment2/12/2019
Has the study received ethics approval?Approved
The purpose of this study is to determine the effect of androgen deprivation therapy, a treatment commonly prescribed in prostate cancer patients, on the effectiveness of medical imaging techniques. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic prostate cancer. Study details: Participants are required to undergo 2 PSMA Scans, the 1st within 28days prior to starting treatment with the medication enzalutamide and the 2nd 14 days after starting enzalutamide. Participants will be required to undergo a physical exam with the Dr which will include a blood test to assess kidney function. The outcome of this study will have important implications for the diagnostic and therapeutic management of metastatic prostate cancer.
Key inclusion criteria
• Male, aged 18 years or over • Metastatic prostate cancer with demonstrated resistance to standard ADT • Eastern Cooperative Oncology Group (ECOG) score 0 or 1 or 2 • Willing and able to comply with all study requirements, including all imaging and pre- and post-study assessments • estimated glomerular filtration rate (eGFR) greater than or equal to 40 mL/min/1.73 m^2
Minimum age18 Years
Can Healthy volunteers participate? No
Key exclusion criteria
• Prostate cancer with significant neuroendocrine or sarcomatoid component • Chemotherapy within previous two months • External beam radiotherapy within previous two months • Current use of abiraterone, or use within previous two months • Known intolerance or hypersensitivity to enzalutamide, or patient in whom enzalutamide is contraindicated • Known hypersensitivity to CT imaging intravenous contrast agent • Known hypersensitivity to any isotope of Ga in any chemical form, or any of the PSMA-targeting ligands • Significant urinary incontinence • Any mental condition or cognitive impairment that may render the patient unable to adequately understand the requirements, nature and possible consequences of the study
Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: GenesisCare
Primary Sponsor Address: 41-43 Bourke road, Alexandria, NSW 2015, Australia
Primary Sponsor Country: Australia
Trial websiteThere is no specific trial-related website.
Contact person for information and recruitmentMiss
GenesisCare, Level 5, 126 Wellington Parade East Melbourne VIC 3002
+61 0408 737 216
Email contact Nicole.Haberman@genesiscare.comAustralia