- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05154162
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI (PRIMARY2)
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Annette VanDer Heyden
- Phone Number: +61488048792
- Email: Annette.VanDerHeyden@petermac.org
Study Contact Backup
- Name: Gaurav Sharma
- Phone Number: +61 3 8559 6830
- Email: Gaurav.Sharma@petermac.org
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2010
- Recruiting
- St Vincent's Hospital
-
Contact:
- Shikha Agrawal
- Email: S.Agrawal@garvan.org.au
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-
Queensland
-
Brisbane, Queensland, Australia, 4006
- Recruiting
- Royal Brisbane and Women's Hospital
-
Contact:
- Karina Lewis
- Email: Karina.Lewis@health.qld.gov.au
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-
South Australia
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Adelaide, South Australia, Australia, 5000
- Recruiting
- Royal Adelaide Hospital
-
Contact:
- Madison Bills
- Email: Madison.Bills@sa.gov.au
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-
Victoria
-
Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter Maccallum Cancer Centre
-
Contact:
- Annette Van Der Heyden
- Phone Number: 0385596651
- Email: Annette.VanDerHeyden@petermac.org
-
Contact:
- Gaurav Sharma, MS
- Phone Number: 03 85596830
- Email: Gaurav.sharma@petermac.org
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Melbourne, Victoria, Australia, 3084
- Recruiting
- Austin Health
-
Contact:
- Tina Chen
- Email: tina.chen@austin.org.au
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Melbourne, Victoria, Australia, 3144
- Recruiting
- Cabrini Health
-
Contact:
- Leyna Tran
- Email: LTran@cabrini.com.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients must meet all the following criteria for study entry:
- Males aged ≥ 18 years at the time of consent
- No previously diagnosed prostate cancer
- No previous prostate biopsy
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
- Intention for prostate biopsy
- Willing and able to comply with all study requirements
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
- Having a PSA >20ng/ml
- Having ≥ cT3 on DRE
- Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Pelvic PSMA PET ± transperineal targeted prostate biopsy
|
PSMA PET/CT (limited to the pelvis)
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
|
Other: Control
No pelvic PSMA PET + 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of sPCa on prostate biopsy
Time Frame: When histology results are available, at an expected average of 14 days post-biopsy
|
sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa.
|
When histology results are available, at an expected average of 14 days post-biopsy
|
Number of men who avoid transperineal prostate biopsy in the experimental arm
Time Frame: When the PSMA PET result is available, at most 28 days after randomisation
|
In the experimental arm, if PSMA PET is negative, the patient does not have biopsy
|
When the PSMA PET result is available, at most 28 days after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of insignificant prostate cancer (isPCa) on prostate biopsy
Time Frame: Within 3 months following randomisation
|
isPCa defined as GS 3+3=6, GG 1 or GS 3+4(≤10%)=7, GG 2
|
Within 3 months following randomisation
|
Cost per quality adjusted life year
Time Frame: Through study completion, estimated up to 2 years
|
cost-effectiveness analysis to assess the cost per quality adjusted life year (QALY) gained associated with the use of PSMA PET in addition to MRI compared with MRI alone for the diagnosis of sPCa.
Importantly, this analysis will take into consideration the impact on costs and QoL associated with the hypothesised reduction in unnecessary biopsies arising from the improved accuracy of PSMA+MRI and the comparative interventions).
|
Through study completion, estimated up to 2 years
|
Health-related quality of life as measured by the EORTC QLQ-C30.
Time Frame: Within 7 days of randomisation and every 6 months ± 30 days after randomisation
|
Quality of life (QoL) will be assessed using QLQ-C30, which contains 30 items across five functional scales, three symptom scales, global health status, and six single items.
Participant responses are collected using a four-point response scale ranging from 'Not at all' to "Very much".
Higher scores indicate better QoL and function, while high scores for the symptom scale represent a high level of symptoms.
|
Within 7 days of randomisation and every 6 months ± 30 days after randomisation
|
Anxiety as measured by the GAD7 in the diagnosis of PCa.
Time Frame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation
|
The generalized anxiety disorder Scale (GAD-7)14 is a 7-item, patient-rated questionnaire for screening and severity measuring of generalised anxiety disorder.
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
|
Within 7 days following randomisation and every 6 months ± 30 days after randomisation
|
Cancer worry in the diagnosis of PCa.
Time Frame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation
|
The modified Cancer Worry Scale adaptation of Cancer Worry Scale is a 3-item questionnaire used in context of cancer worry in abnormal PSA levels in men participating in community screening program.
The score is calculated by assigning scores of 1, 2, 3, and 4, to the categories 'not at all or rarely', 'sometimes', 'often', and 'a lot', respectively, and adding together the scores for the 3 questions.
A final question asks about feelings of distress related to cancer risk.
|
Within 7 days following randomisation and every 6 months ± 30 days after randomisation
|
Number of biopsy cores
Time Frame: Within 3 months following randomisation
|
Experimental arm: For patients with a positive PSMA PET, the images, the report and a simplified template will be made available to the treating urologist. Up to four identified lesions on PSMA PET and/or MRI will be targeted with each lesion having a minimum 5 cores. Control arm: 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. |
Within 3 months following randomisation
|
Incidence of complications following transperineal prostate biopsy.
Time Frame: Within 7 days following randomisation and at 3 and 6 months after randomisation
|
Complications following biopsy will be assessed with a modified questionnaire validated in the PRECISION trial.
Part 1 following randomisation is a 9 item questionnaire.
Part 2 is a 23 item questionnaire administered at 3 and 6 months to assess complications from transperineal prostate biopsy.
The following complications will be assessed via these forms: fever, blood in urine, blood in semen, blood in stool, acute urinary retention, erectile dysfunction, urinary incontinence, urinary tract infection and pain in the perineum.
|
Within 7 days following randomisation and at 3 and 6 months after randomisation
|
Incidence of erectile dysfunction following transperineal prostate biopsy
Time Frame: Within 7 days following randomisation and at 3 and 6 months after randomisation
|
The Sexual Health Inventory for Men (SHIM) is an adapted version of the 5 item International Index of Erectile Function (IIEF-5) score, developed to diagnose the presence and severity of erectile dysfunction.
This validated questionnaire has a range of scores from 1 to 25, grading erectile dysfunction into 5 categories (none, mild, mild to moderate, moderate and severe).
|
Within 7 days following randomisation and at 3 and 6 months after randomisation
|
Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2)
Time Frame: Within 28 days following randomisation
|
Measured in the experimental arm in patients with positive PSMA PET and negative MRI (PIRADS 2).
sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2
|
Within 28 days following randomisation
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Hofman, Peter MacCallum Cancer Centre, Australia
- Principal Investigator: Louise Emmett, St Vincent's Sydney
- Principal Investigator: Mark Frydenberg, Cabrini Health
- Principal Investigator: Sze-Ting Lee, Austin Health
- Principal Investigator: Matthew Roberts, Royal Brisbane and Women's Hospital
- Principal Investigator: Yang Du, Royal Adelaide Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20/043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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