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Trial registered on ANZCTR


Registration number
ACTRN12617001318370
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
13/09/2017
Date last updated
13/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The “PUMP” Trial - Comparison of diagnostic accuracy of PSMA PET/MRI, USS MRI Fusion Biopsy and "Prolaris" genomic risk stratifier in reclassification of men on Active Surveillance with low risk prostate cancer
Scientific title
The “PUMP” Trial - Comparison of diagnostic accuracy of PSMA PET/MRI, USS MRI Fusion Biopsy and "Prolaris" genomic risk stratifier in reclassification of men on Active Surveillance with low risk prostate cancer
Secondary ID [1] 292639 0
None
Universal Trial Number (UTN)
Trial acronym
PUMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 304373 0
Condition category
Condition code
Cancer 303703 303703 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will attend a 68Ga-PSMA PET/MR scan (combining PET and mpMRI), a transperineal template saturation prostate biopsy, a Biojet MRI USS Fusion transperineal prostate biopsy when having transperineal biopsy if lesions of interest are identified on the 68Ga-PSMA PET/MR scan, and will have a Prolaris Cell Cycle Progression test on previous samples.

[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA)
It is an intravenous (IV) solution. The strength is 150MBq. One infusion is needed for the scan. The infusion of the 68Ga-PSMA ligands takes about 45 mins. Then, 68Ga-PSMA PET/MR scan will be performed. The scan will take 1-2 hours.

Multi Parameteric Magnetic Resonance Imaging (mpMRI)
This type of scan does not use radiation. As in standard MRI, mpMRI uses magnetic signal to build up a picture of the prostate. However, in addition to this, mpMRI uses additional types of magnetic signals to build up more complete images of the prostate. This gives an overall assessment of the prostate and identifies areas of suspicion that can be targeted specifically for biopsy. Use of mpMRI approach increases the accuracy of the scan result and subsequent biopsy but we cannot be sure if this is the best approach without doing the study.

Positron Emission Tomography (PET)
PET scans are often used in the management of cancer and for diagnosis of suspected cancer conditions. This type of scan involves the use of a PET scanner and a radiotracer (radioactive agent). The PET radiotracer used in this study is 68Ga PSMA ligand which is a radioactive protein marker. PET scans may be performed with low dose whole body computer tomography or MRI.

The new imaging we are proposing is a hybrid of the above two described techniques. Both will occur at the same within the same machine. As the images are taken at the same time, there is a potential for significant improvement in the quality of the imaging with improved higher grade cancer detection rate on subsequent biopsy.

Biojet MRI USS Fusion Transperineal Prostate Biopsy
It is a technology used to assist in biopsy the prostate. With the advent of mpMRI of the prostate, identification of lesions suspicious for high-grade cancer in the prostate for targeting is now possible with high accuracy. The Biojet technology allows fusion of the MRI and PSMA PET imaging previously performed to live Transrectal Ultrasound (TRUS) imaging in real-time (via a computer and provided software) in order to more accurately target lesions of interest. The biopsies are also performed via a transperineal approach (through the skin of the perineum between anus and base of scrotum) which allows more accurate localisation of lesions and better access to the anterior zones, with decreased potential infectious complications as a transrectal biopsy approach is avoided. These biopsies are performed under general anaesthetic at the Princess Alexandra Hospital within 3 months after the 68Ga-PSMA PET/MR scan. The biopsy procedure will take 45 min and will be performed by Urologists.

Prolaris Cell Cycle Progression (CCP) Score
It is a commercially available genetic test performed on the cancer sample obtained from the prostate biopsy. This test looks at the expression of 31 genes (termed cell cycle progression genes) normalized to 15 housekeeping genes in the cancer sample. This expression along with clinical information are used to calculate the CCP score which indicates how aggressively the individual cancer may behave in the future in comparison to other patients with similar clinical criteria. This may assist participants and the surgeon in the decision to continue on an Active Surveillance (AS) protocol or proceed with active treatment (surgery or radiation). This new test has never been compared with PSMA PET MRI imaging and fusion biopsy in its ability to accurately identify men with more aggressive cancer who are on an AS protocol.
Intervention code [1] 298876 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator: Transperineal Template Prostate Biopsy.
The transperineal template prostate biopsy is administered to all participants in this study as a standard of care procedure regardless of whether target lesions are identified in the 68Ga PSMA PET/MRI scan. The procedure requires a brief general anaesthetic and takes about 45 minutes. This approach has been accepted as the “gold standard”.
Control group
Active

Outcomes
Primary outcome [1] 303069 0
Identification of significant cancer (ISUP GG >=3) on transperineal template biopsy will be compared to Biojet MRI USS Fusion biopsy of mpMRI and/or PSMA PET identification of significant cancer and compared to the Prolaris Cell Cycle Progression (CCP) score indicating significant cancer on previous biopsy. The diagnostic accuracy of PSMA PET/MRI, mp MRI, Biojet MRI USS Fusion Biopsy and “Prolaris” genomic risk stratifier will be reported such as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). The accuracy will be compared with respect to sensitivity using McNemar test or exact binomial test. The statistical analyses will be performed using with SPSS Statistics.
Timepoint [1] 303069 0
At the end of study
Secondary outcome [1] 337817 0
Cost - utility analysis will identify most accurate method for re-classification of higher risk cancer and will compare the direct and indirect costs of each methods
Timepoint [1] 337817 0
At the end of the study

Eligibility
Key inclusion criteria
1. 40 to 75 years of age, with a life expectancy of at least 10 years with pathologically diagnosed low risk prostate cancer deemed suitable for active surveillance (based on NICE criteria) or definitive therapy of curative intent
2. History of previous prostate biopsy diagnosing low risk prostate cancer no sooner than 6 weeks prior.
3. No known problems with peripheral intravenous or central line access
4. Able to provide informed signed consent
Minimum age
40 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 40 or greater than 75 years
2. Unable to lie flat during or unable to tolerate PET/MRI
3. Contraindication to PET scan or [68Ga]gallium-labelled PSMA ligand
4. Claustrophobia not manageable by oral sedatives ie Temazepam
5. Renal impairment (eGFR less than 30)
6. Contraindication to confirmatory prostate biopsy of identified lesions under general anaesthetic
7. Not suitable for definitive therapy of curative intent

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2017
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8820 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 8821 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [3] 8822 0
Redland Hospital - Cleveland
Recruitment hospital [4] 8823 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 16944 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 16945 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 16946 0
4163 - Cleveland
Recruitment postcode(s) [4] 16947 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 297267 0
Charities/Societies/Foundations
Name [1] 297267 0
Princess Alexandra Research Foundation
Country [1] 297267 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane QLD 4102
Country
Australia
Secondary sponsor category [1] 296241 0
None
Name [1] 296241 0
Address [1] 296241 0
Country [1] 296241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298385 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 298385 0
Centres for Health Research, Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane, QLD 4102
Ethics committee country [1] 298385 0
Australia
Date submitted for ethics approval [1] 298385 0
16/03/2017
Approval date [1] 298385 0
13/06/2017
Ethics approval number [1] 298385 0
HREC/17/QPAH/180

Summary
Brief summary
The primary purpose of this trial is to evaluate the comparative accuracy of different scans and biopsy diagnostic techniques for low risk prostate cancer.

Who is it for?
You may be eligible to enroll in this trial if you are aged 40 to 75 years and have been diagnosed with low risk prostate cancer, and with a life expectancy of at least 10 years.

Study details
All participants enrolled in this trial will receive a 68Ga-HBED-CC PSMA PET/MRI of the prostate and pelvis, which involves injection of a radioactive substance (68Ga-HBED-CC PSMA) following by lying in the scanner for 1-2 hours. All participants will then receive a transperineal biopsy of the prostate. Participants who have lesions identified on the 68Ga-HBED-CC PSMA PET/MRI scan will receive a biopsy procedure targeting those lesions when they have transperineal biopsy of the prostate. Researchers will then complete genetic analysis on the previous biopsy sample.

The results of the scanning techniques, the biopsy result and the genetic testing score will all be compared to determine the most accurate technique for reclassifying men previously diagnosed with low risk prostate cancer into higher risk categories.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76910 0
Dr Ian Vela
Address 76910 0
Department of Urology, Princess Alexandra Hospital., 199 Ipswich Rd, Brisbane QLD 4102
Country 76910 0
Australia
Phone 76910 0
+61 7 3176 7957
Fax 76910 0
Email 76910 0
[email protected]
Contact person for public queries
Name 76911 0
Ian Vela
Address 76911 0
Department of Urology, Princess Alexandra Hospital., 199 Ipswich Rd, Brisbane QLD 4102
Country 76911 0
Australia
Phone 76911 0
+61 7 3176 7957
Fax 76911 0
Email 76911 0
[email protected]
Contact person for scientific queries
Name 76912 0
Ian Vela
Address 76912 0
Department of Urology, Princess Alexandra Hospital., 199 Ipswich Rd, Brisbane QLD 4102
Country 76912 0
Australia
Phone 76912 0
+61 7 3176 7957
Fax 76912 0
Email 76912 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
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