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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05154162




Registration number
NCT05154162
Ethics application status
Date submitted
25/10/2021
Date registered
10/12/2021
Date last updated
28/07/2023

Titles & IDs
Public title
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI
Scientific title
Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer
Secondary ID [1] 0 0
20/043
Universal Trial Number (UTN)
Trial acronym
PRIMARY2
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - PSMA PET/CT
Treatment: Surgery - Transperineal template prostate biopsy
Treatment: Surgery - Transperineal targeted prostate biopsy

Experimental: Experimental - Pelvic PSMA PET ± transperineal targeted prostate biopsy

Other: Control - No pelvic PSMA PET + transperineal template prostate biopsy


Diagnosis / Prognosis: PSMA PET/CT
PSMA PET/CT (limited to the pelvis)

Treatment: Surgery: Transperineal template prostate biopsy
Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores, dependent on prostate volume. MRI will be available for any additional targeted biopsies required. Transperineal template biopsies must be labelled appropriately and sent for histopathological analysis.

Treatment: Surgery: Transperineal targeted prostate biopsy
If the PSMA PET/CT is normal, transperineal prostate biopsy would be omitted If the PSMA PET/CT is abnormal, transperineal prostate biopsies would be performed targeting the MRI (done prior to study) and PSMA PET/CT images
Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of sPCa on prostate biopsy
Timepoint [1] 0 0
When histology results are available, at an expected average of 14 days post-biopsy
Primary outcome [2] 0 0
Number of men who avoid transperineal prostate biopsy in the experimental arm
Timepoint [2] 0 0
When the PSMA PET result is available, at most 28 days after randomisation
Secondary outcome [1] 0 0
Presence of insignificant prostate cancer (isPCa) on prostate biopsy
Timepoint [1] 0 0
Within 3 months following randomisation
Secondary outcome [2] 0 0
Cost per quality adjusted life year
Timepoint [2] 0 0
Through study completion, estimated up to 2 years
Secondary outcome [3] 0 0
Health-related quality of life as measured by the EORTC QLQ-C30.
Timepoint [3] 0 0
Within 7 days of randomisation and every 6 months ± 30 days after randomisation
Secondary outcome [4] 0 0
Anxiety as measured by the GAD7 in the diagnosis of PCa.
Timepoint [4] 0 0
Within 7 days following randomisation and every 6 months ± 30 days after randomisation
Secondary outcome [5] 0 0
Cancer worry in the diagnosis of PCa.
Timepoint [5] 0 0
Within 7 days following randomisation and every 6 months ± 30 days after randomisation
Secondary outcome [6] 0 0
Number of biopsy cores
Timepoint [6] 0 0
Within 3 months following randomisation
Secondary outcome [7] 0 0
Incidence of complications following transperineal prostate biopsy.
Timepoint [7] 0 0
Within 7 days following randomisation and at 3 and 6 months after randomisation
Secondary outcome [8] 0 0
Incidence of erectile dysfunction following transperineal prostate biopsy
Timepoint [8] 0 0
Within 7 days following randomisation and at 3 and 6 months after randomisation
Secondary outcome [9] 0 0
Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2)
Timepoint [9] 0 0
Within 28 days following randomisation

Eligibility
Key inclusion criteria
* Patients must meet all the following criteria for study entry:

1. Males aged = 18 years at the time of consent
2. No previously diagnosed prostate cancer
3. No previous prostate biopsy
4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:

* PI-RADS 2 AND =1 red flag defined as:

* PSA density >0.1
* Abnormal DRE
* Strong family history (1 first degree relative or =2 second degree)
* BRCA mutation
* PSA >10
* PSA doubling time <36 months
* PSA velocity >0.75/year
* PI-RADS 3
5. Intention for prostate biopsy
6. Willing and able to comply with all study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who meet any of the following criteria will be excluded from study entry:

1. Having a PSA >20ng/ml
2. Having = cT3 on DRE
3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Austin Health - Melbourne
Recruitment hospital [6] 0 0
Cabrini Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4006 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3144 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital, Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Trial website
https://clinicaltrials.gov/study/NCT05154162
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Hofman
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gaurav Sharma
Address 0 0
Country 0 0
Phone 0 0
+61 3 8559 6830
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05154162