Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000608561
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
11/06/2015
Date last updated
11/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
68Ga-PSMA PET-CT in biochemical relapse following primary treatment of Prostate Carcinoma (PCa)
Scientific title
Clinical utility of Gallium 68 Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) imaging in patients with initial biochemical relapse following definitive surgery or radiotherapy for prostate carcinoma (PCa), to determine the sensitivity of 68Ga-PSMA imaging in the detection of PCa and using intention to treat analysis to assess change in management.
Secondary ID [1] 286768 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Prostate Carcinoma 295143 0
Condition category
Condition code
Cancer 295385 295385 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gallium 68 Prostate Specific Membrane Antigen Positron emission tomography (68Ga-PSMA PET) scans will be performed on study participants within 4 weeks of study recruitment. A follow up scan will be performed 6 months later. 68Ga PSMA PET imaging requires tracer administration through a peripheral intravenous cannula. 2MBq/kg of 68Ga-PSMA will be administered intravenously as a slow push. At approximately1 hour following tracer administration, PET emission and transmission data will be acquired from mid-thigh to skull vertex. Duration of the imaging scan is approximately 40 minutes.
Intervention code [1] 291921 0
Early detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295121 0
Detection of disease on initial and follow up 68Ga-PSMA PET-CT imaging.
Timepoint [1] 295121 0
Initial imaging will occur with 4 weeks of study consent, follow up imaging will be at 6 monts post consent.
Secondary outcome [1] 314811 0
Assessment of change in management based on intention to treat analysis
Timepoint [1] 314811 0
Intention to treat analysis will be performed after the initial 68Ga-PSMA PET scan. Intention to treat forms will be completed by the referring physician prior to the initial scan and within two weeks post scan.

Eligibility
Key inclusion criteria
Histologically confirmed prostate carcinoma
Initial biochemical relapse following definitive treatment (Surgery or XRT) for prostate carcinoma or biochemical relapse at least 6 months following previous systemic (hormonal) treatment. (Biochemical relapse defined as PSA>0.2ng/mL at >6 weeks post radical prostatectomy or a PSA level 2 ng/mL above the previous PSA nadir measured >3 months after external beam radiotherapy-EBRT).
Standard staging imaging, bone scan and abdominal CT, performed within 4 weeks of referral, showing no or oligometastatic disease. (Oligometastatic disease includes up to a maximum of four lesions.)
No other active neoplastic disease
Able to undergo study procedures / treatment
Able to provide informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Disseminated prostate carcinoma
Hormone refractory prostate carcinoma

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3814 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 9698 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291312 0
Hospital
Name [1] 291312 0
Sir Charles Gairdner Hospital
Country [1] 291312 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
NEDLANDS
WA
6009
Country
Australia
Secondary sponsor category [1] 289992 0
None
Name [1] 289992 0
Address [1] 289992 0
Country [1] 289992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292877 0
Sir Charles Gairdner Group (SCGG) Human Research Ethics Committee
Ethics committee address [1] 292877 0
Sir Charles Gairdner Hospital
2nd floor, A Block
Hospital Avenue
QEII Medical site
NEDLANDS
WA 6009
Ethics committee country [1] 292877 0
Australia
Date submitted for ethics approval [1] 292877 0
Approval date [1] 292877 0
19/03/2015
Ethics approval number [1] 292877 0
2015-013

Summary
Brief summary
This study is investigating the sensitivity of Gallium 68 -Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) imaging in the detection of recurrent prostate carcinoma. Intention to treat analysis will be used to assess the impact of the 68Ga-PSMA PET on clinical management. Who is it for? You may be eligable for this study if you are over 40 years of age and have initial biochemical relapse, based on serum prostate specific antigen (PSA), following surgery or radiotherapy for prostate carcinoma, and have either no evidence of disease, or have oligometastatic disease (up to a maximum of four lesions) on current staging imaging. Study details: All participants in this study will undergo 2 68Ga-PSMA PET scans, 1 within a month of joining the trial and 1 six months later. These scans would not normally be part of routine care. The scans involve injection of a radioactive tracer. Participants will be followed up 3 months after the final scan to determine what treatment has been performed. This information will be used to evaluate the usefulness of the 68Ga-PSMA PET scans in detecting recurrent prostate carcinoma and determining how the scans affect clinical management. There are no additional appointments to attend outside your normal treatment visits except for the 2 PET scan visits, which should take approximately 2-3 hours. All followup data will be collected from your medical notes when you attend your routine treatment appointments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57466 0
Dr Micheal McCarthy
Address 57466 0
Nuclear Medicine Department
Fiona Stanley Hospital
102 - 118 Murdoch Drive
Murdoch
WA 6150
Country 57466 0
Australia
Phone 57466 0
+61 8 9224 1118
Fax 57466 0
Email 57466 0
Michael.McCarthy@health.wa.gov.au
Contact person for public queries
Name 57467 0
Ms Elaine Campbell
Address 57467 0
WA PET Service Sir Charles Gairdner Hospital 1st floor, G Block Hospital
Avenue NEDLANDS WA 6009
Country 57467 0
Australia
Phone 57467 0
+61 8 9346 2322
Fax 57467 0
+61 8 9346 3610
Email 57467 0
Elaine.Campbell@health.wa.gov.au
Contact person for scientific queries
Name 57468 0
A/Prof Roslyn Francis
Address 57468 0
WA PET Service Sir Charles Gairdner Hospital Hospital Avenue NEDLANDS
WA 6009
Country 57468 0
Australia
Phone 57468 0
+61 8 9346 2322
Fax 57468 0
+61 8 9346 3610
Email 57468 0
Ros.Francis@health.wa.gov.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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Multicenter Prospective Clinical Trial of 68Gallium PSMA HBED-CC PET-CT Restaging in Biochemically Relapsed Prostate Carcinoma: Oligometastatic Rate and Distribution Compared With Standard Imaging.2019https://dx.doi.org/10.1016/j.ijrobp.2019.03.014
EmbaseFully automatic prognostic biomarker extraction from metastatic prostate lesion segmentations in whole-body [68Ga]Ga-PSMA-11 PET/CT images.2022https://dx.doi.org/10.1007/s00259-022-05927-1
EmbasePrognostic utility of RECIP 1.0 with manual and AI-based segmentations in biochemically recurrent prostate cancer from [68Ga]Ga-PSMA-11 PET images.2023https://dx.doi.org/10.1007/s00259-023-06382-2
N.B. These documents automatically identified may not have been verified by the study sponsor.