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Trial registered on ANZCTR


Registration number
ACTRN12618001696280
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
15/10/2018
Date last updated
15/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Detecting new bone metastases in patients on androgen deprivation therapy
Scientific title
Assessing the emergence of new bone lesions in primary prostate cancer patients at high risk of bone metastasis starting androgen deprivation therapy: Implications for current treatment intervention
Secondary ID [1] 296094 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 309673 0
Condition category
Condition code
Cancer 308475 308475 0 0
Prostate
Cancer 308476 308476 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to improve knowledge around the way that cancer spreads in men with advanced prostate cancer who receive targeted radiation therapy and androgen deprivation therapy (ADT).

This study does not direct treatment and any treatment decisions will be based on the recommendation of your treating doctor. This study is looking at the effects on bone lesions in individuals receiving this treatment. At study enrolment a 68Ga-PSMA PET CT scan will occur as part of standard of care treatment.

A 68Ga-PSMA PET CT is a nuclear medicine imaging test used in prostate cancer and it has higher diagnostic efficacy than conventional imaging. Radioactive tracers are injected and then taken up by tissues in your body. Activity within your organs are then detected by the PET scanner which shows how tissue and organs are working. This test takes approximately 2 hours with the scan itself taking up to half an hour. This nuclear medicine examination is considered safe with almost no reported adverse reactions attributable to the radiopharmaceuticals used.

This study requires two additional 68Ga-PSMA PET CT scans that are beyond standard of care. These scans occur at 6 and 12 months post enrolment. There are also optional blood tests that occur at enrolment, 6 and 12 months post enrolment. Blood tests are at the discretion of the individual participant.
Intervention code [1] 312435 0
Diagnosis / Prognosis
Intervention code [2] 312525 0
Early detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307455 0
Number of new bone lesions identified on 68Ga-PSMA PET CT scan
Timepoint [1] 307455 0
At 6 months and 12 months post enrolment
Secondary outcome [1] 351968 0
The proportion of participants who started bisphosphonates or other therapeutics designed to block bone reabsorption as measured by medication history
Timepoint [1] 351968 0
At 12 months post enrolment
Secondary outcome [2] 352507 0
Change in Lactate dehydrogenase (LDH) levels in blood from baseline
Timepoint [2] 352507 0
6 and 12 months post enrolment
Secondary outcome [3] 352839 0
Change in complete blood count (CBC) levels in blood from baseline
Timepoint [3] 352839 0
6 and 12 months post enrolment
Secondary outcome [4] 352840 0
Change in electrolytes urea creatinine (EUC) levels in blood from baseline
Timepoint [4] 352840 0
6 and 12 months post enrolment
Secondary outcome [5] 352841 0
Change in calcium-magnesium-phosphate (CMP) levels in blood from baseline
Timepoint [5] 352841 0
6 and 12 months post enrolment
Secondary outcome [6] 352842 0
Change in Testosterone levels in blood from baseline
Timepoint [6] 352842 0
6 and 12 months post enrolment
Secondary outcome [7] 352843 0
Change in liver function test (LFT) levels in blood from baseline
Timepoint [7] 352843 0
6 and 12 months post enrolment
Secondary outcome [8] 352844 0
Change in prostate specific antigen (PSA) levels in blood from baseline
Timepoint [8] 352844 0
6 and 12 months post enrolment

Eligibility
Key inclusion criteria
- Pathologically confirmed adenocarcinoma of prostate
- Men presenting high risk of metastatic disease.
- Gleason score 7-10
- Deemed suitable by a medical oncologist to start targeted radiation therapy and androgen deprivation therapy.
- Blood tests:
a) haemoglobin > 100g/L
b) Platelets > 100 x 10^9/L
c) Total white cell count > 4 x 10^9/L
-Willingness to give written, informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants whose prostate cancer is not high risk of metastasis;
- Participants who refuse to join the trial or are unable consent;
- Participants who cannot remain still for at least 30 minutes to comply with imaging requirements.
- Participants who have no PSMA receptor activity (approximately 5-10% of the population) and provide a negative baseline scan.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11912 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 24049 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 300682 0
Charities/Societies/Foundations
Name [1] 300682 0
The Prostate Cancer Foundation of Australia
Country [1] 300682 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Garvan Institues of Medical Research
Address
384 Victoria St
Darlinghurst
NSW, 2010
Country
Australia
Secondary sponsor category [1] 300211 0
None
Name [1] 300211 0
Address [1] 300211 0
Country [1] 300211 0
Other collaborator category [1] 280353 0
Hospital
Name [1] 280353 0
St Vincent's Hosptial (Darlinghurst)
Address [1] 280353 0
370 Victoria St
Darlinghurst
NSW 2010
Country [1] 280353 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301464 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 301464 0
Translational Research Centre
97-105 Boundary Street
Darlinghurst
NSW 2010
Ethics committee country [1] 301464 0
Australia
Date submitted for ethics approval [1] 301464 0
27/11/2017
Approval date [1] 301464 0
16/09/2018
Ethics approval number [1] 301464 0
HREC/17/SVH/375

Summary
Brief summary
This study's purpose is to assess new bones lesion(s) in prostate cancer participants starting androgen deprivation therapy (ADT).

Who is it for?
You may be eligible to join this study if you have prostate cancer with a high risk of metastatic disease and your treating doctor recommends starting ADT and targeted radiotherapy.

Study Details:
Participants in this study will undergo a 68Ga-PSMA PET CT at study entry. Participants will have two additional 68Ga-PSMA PET CT at 6 and 12 months.

Participants will be followed up per routine clinical care. Participants have the option of providing optional blood test.

It is hoped that this research will provide insight in the incidence and mechanism of bone lesions in advanced prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87098 0
Prof Peter Croucher
Address 87098 0
The Garvan Institute of Medical Research
Bone Biology Division
384 Victoria St
Darlinghurst
NSW 2010
Country 87098 0
Australia
Phone 87098 0
+612 9292 8243
Fax 87098 0
Email 87098 0
[email protected]
Contact person for public queries
Name 87099 0
Matthew Summers
Address 87099 0
The Garvan Institute of Medical Research
Bone Biology Division
384 Victoria St
Darlinghurst
NSW 2010
Country 87099 0
Australia
Phone 87099 0
+61 415803747
Fax 87099 0
Email 87099 0
[email protected]
Contact person for scientific queries
Name 87100 0
Matthew Summers
Address 87100 0
The Garvan Institute of Medical Research
Bone Biology Division
384 Victoria St
Darlinghurst
NSW 2010
Country 87100 0
Australia
Phone 87100 0
+61 415803747
Fax 87100 0
Email 87100 0
[email protected]

No information has been provided regarding IPD availability


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.