Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000720112
Ethics application status
Approved
Date submitted
25/03/2019
Date registered
13/05/2019
Date last updated
26/08/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer
Scientific title
Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer
Secondary ID [1] 297784 0
ENHA01
Universal Trial Number (UTN)
U1111-1230-5149
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 312134 0
Condition category
Condition code
Cancer 310687 310687 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
68Ga-PSMA-PET/CT scan will be administered in a registered nuclear medicine department by a nuclear med physician. This scan is considered standard of care for patients and this trial requires 1 additional scan under the same conditions as a standard PSMA scan. All participants are will be undergoing enzalutamide as standard of care. PSMA scans takes approx. 2-3 hours to complete. The second scan will be 7 weeks from the baseline scan. The Enzalitamide dosing is based on clinician choice (medical oncologist) Enzalutimdie will commence at Week 5 (4 weeks post the 1st PSMA Scan) will continue throughout study as prescribed by treating Med Onc.
Intervention code [1] 314020 0
Diagnosis / Prognosis
Comparator / control treatment
This study has no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319534 0
To evaluate if diagnostic sensitivity of 68Ga-PSMA-PET/CT imaging in patients with metastatic prostate cancer is enhanced by androgen blockade with enzalutamide, as measured by any increase in SUV (max) OR any increase in number of lesions detected in an individual patient
Timepoint [1] 319534 0
The second 68Ga-PSMA-PET/CT scan performed 14 days following the start of enzalutamide treatment
Secondary outcome [1] 368611 0
NIL
Timepoint [1] 368611 0
NIL

Eligibility
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 age
18 Years
Maximum age
No limit
Sex
Males
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable, as the trial in non-randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable, as the trial in non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No statistical analysis is involved in the design of this trial

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
10/08/2020
Actual
Sample size
Target
40
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13470 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 26083 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302307 0
Commercial sector/Industry
Name [1] 302307 0
Telix Pharmaceuticals
Country [1] 302307 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
41-43 Bourke road, Alexandria, NSW 2015, Australia
Country
Australia
Secondary sponsor category [1] 302191 0
None
Name [1] 302191 0
Address [1] 302191 0
Country [1] 302191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302982 0
Bellberry Human Ethics Committee
Ethics committee address [1] 302982 0
123 Glen Osmond Road
Eastwood
SA 5063
Ethics committee country [1] 302982 0
Australia
Date submitted for ethics approval [1] 302982 0
02/04/2019
Approval date [1] 302982 0
30/07/2019
Ethics approval number [1] 302982 0

Summary
Brief summary
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.


Trial website
There is no specific trial-related website.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92062 0
A/Prof Nat Lenzo
Address 92062 0
GenesisCare,
41-43 Bourke road,
Alexandria,
NSW 2015,
Australia
Country 92062 0
Australia
Phone 92062 0
+61 0402345665
Fax 92062 0
Email 92062 0
[email protected]
Contact person for public queries
Name 92063 0
Miss Nicole Haberman
Address 92063 0
GenesisCare,
Level 5, 126 Wellington Parade
East Melbourne
VIC 3002
Country 92063 0
Australia
Phone 92063 0
+61 0408 737 216
Fax 92063 0
Email 92063 0
[email protected]
Contact person for scientific queries
Name 92064 0
Dr Danielle Meyrick
Address 92064 0
GenesisCare,
41-43 Bourke road,
Alexandria,
NSW 2015,
Australia
Country 92064 0
Australia
Phone 92064 0
+61 0419 610 137
Fax 92064 0
Email 92064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No publication policy has yet been implemented for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.