Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001116314
Ethics application status
Approved
Date submitted
24/07/2017
Date registered
31/07/2017
Date last updated
31/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
To determine whether androgen deprivation therapy or androgen blockage therapy upregulates receptor activity of Gallium68 Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans for men with castrate resistant prostate cancer.
Scientific title
The impact of androgen deprivation therapy or androgen blockage therapy on the upregulation receptor activity of Gallium68 Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans in men with castrate resistant prostate cancer and the use of PSMA targeted therapies.
Secondary ID [1] 292504 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ADT and Me Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 304143 0
Condition category
Condition code
Cancer 303472 303472 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treating medical oncologist will firstly review that potential participant for eligibility to participate in the study. The participant will then be asked to participant in the study and if the participant consents to the study, the participant will receive a GaPSMA PET scan, free of charge.

A GaPSMA PET scan will involve a needle inserted into the arm and the participant will be injected with a small volume of 68Ga-PSMA, the imaging agent. The participant will be placed under the PET scanner, and some pictures will be taken of the whole body about 45 minutes after injection. The scan will take 30 minutes.

If the GaPSMA PET scan detects any cancer, the participant will continue with study. If the GaPSMA PET scan does not detect any cancer, then the participant is withdrawn from the study. Irrespective of whether or not the GaPSMA PET scan detects any cancer, the participant will receive clinical treatment as indicated.

The eligible participant will return to have PSMA PET scans at days 9, 18 and 28. The participant will continue with either ADT or androgen blockade treatment as clinically required. Clinical information and imaging results will be collected at these times points (baseline, Days 9, 18 and 28). The GaPSMA PET scan will occur at St Vincent’s Hospital Sydney.
Intervention code [1] 298690 0
Early detection / Screening
Intervention code [2] 298729 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302843 0
The upregulation receptor activity of GaPSMA PET scans will be measured at anatomical site, semi quantitative intensity (SUVmax), and a reporter ‘certainty’ score for each lesion (definitely negative, probably negative, probably positive and definitely positive).
Timepoint [1] 302843 0
Baseline and at day 9, 18 and 28 days of ADT treatment or androgen blockade treatment.
Secondary outcome [1] 337357 0
Participant's composite health status (routine clinical testings, treatment plans and well being) will be collected through a review of the participant's medical record.
Timepoint [1] 337357 0
Baseline, Days 9, 18 and 28

Eligibility
Key inclusion criteria
Participants meeting all of these criteria are eligible for the study:
1. Castrate sensitive metastatic prostate cancer commencing androgen deprivation
2. Male, aged 18 years or older
3. Pathologically confirmed adenocarcinoma of prostate
4. Metastatic prostate cancer (> 4 extra-prostatic lesions) confirmed on imaging (sites of disease not relevant)
5. Gleason score 7-10
6. GaPSMA positive disease on screening PET CT
7. Provision of written informed consent.

OR

1. Castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide)
2. Male, aged 18 years or older
3. Pathologically confirmed adenocarcinoma of prostate
4. Metastatic prostate cancer (> 4 extra-prostatic lesions) confirmed on imaging (sites of disease not relevant)
5. Gleason score 7-10
6. GaPSMA positive disease on screening PET CT
7. Provision of written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prostate cancer that is not metastatic
2. Prostate cancer that is not measurable on GaPSMA PET CT (5% of all prostate cancers)
3. Patients who refuse to join the trial or are unable to consent.
4. Patients who cannot lie still for at least 30 minutes or comply with imaging.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Two Cohorts:
10 men with castrate sensitive metastatic prostate cancer commencing androgen deprivation therapy for clinical reasons.
10 men with castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide) for clinical reasons.

This is a prospective, non-randomised pilot study. A further larger study maybe developed if findings confirms the hypothesis that there is an association between androgen receptor and PSMA receptor.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/07/2017
Date of last participant enrolment
Anticipated
24/07/2018
Actual
Date of last data collection
Anticipated
24/08/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8585 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 16693 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297076 0
Other
Name [1] 297076 0
The Garvan Institute of Medical Research
Country [1] 297076 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 296079 0
None
Name [1] 296079 0
Address [1] 296079 0
Country [1] 296079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298254 0
St Vincent's Hospital Sydney HREC
Ethics committee address [1] 298254 0
Ethics committee country [1] 298254 0
Australia
Date submitted for ethics approval [1] 298254 0
27/01/2017
Approval date [1] 298254 0
04/04/2017
Ethics approval number [1] 298254 0
HREC/17/SVH/25

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76486 0
A/Prof Louise Emmett
Address 76486 0
Department of Nuclear Medicine
St Vincent’s Hospital
Victoria St
DARLINGHURST NSW 2010
Country 76486 0
Australia
Phone 76486 0
+61 2 8382 2621
Fax 76486 0
Email 76486 0
l.emmett@unsw.edu.au
Contact person for public queries
Name 76487 0
Quoc Nguyen
Address 76487 0
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010
Country 76487 0
Australia
Phone 76487 0
+61 2 9355 5785
Fax 76487 0
Email 76487 0
q.nguyen@garvan.org.au
Contact person for scientific queries
Name 76488 0
Quoc Nguyen
Address 76488 0
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010
Country 76488 0
Australia
Phone 76488 0
+61 2 9355 5785
Fax 76488 0
Email 76488 0
q.nguyen@garvan.org.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes http://jnm.snmjournals.org/content/60/7/950.long

Documents added automatically
No additional documents have been identified.