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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
Titles & IDs
Public title
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI
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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
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Secondary ID [1]
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20/043
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Universal Trial Number (UTN)
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Trial acronym
PRIMARY2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Diagnosis / Prognosis
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence of sPCa on prostate biopsy
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Assessment method [1]
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sPCa defined as Gleason score 3+4(\>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa.
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Timepoint [1]
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When histology results are available, at an expected average of 14 days post-biopsy
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Primary outcome [2]
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Number of men who avoid transperineal prostate biopsy in the experimental arm
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Assessment method [2]
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In the experimental arm, if PSMA PET is negative, the patient does not have biopsy
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Timepoint [2]
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When the PSMA PET result is available, at most 28 days after randomisation
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Secondary outcome [1]
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Presence of insignificant prostate cancer (isPCa) on prostate biopsy
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Assessment method [1]
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isPCa defined as GS 3+3=6, GG 1 or GS 3+4(=10%)=7, GG 2
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Timepoint [1]
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Within 3 months following randomisation
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Secondary outcome [2]
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Cost per quality adjusted life year
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Assessment method [2]
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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).
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Timepoint [2]
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Through study completion, estimated up to 2 years
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Secondary outcome [3]
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Health-related quality of life as measured by the EORTC QLQ-C30.
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Assessment method [3]
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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.
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Timepoint [3]
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Within 7 days of randomisation and every 6 months ± 30 days after randomisation
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Secondary outcome [4]
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Anxiety as measured by the GAD7 in the diagnosis of PCa.
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Assessment method [4]
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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.
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Timepoint [4]
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Within 7 days following randomisation and every 6 months ± 30 days after randomisation
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Secondary outcome [5]
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Cancer worry in the diagnosis of PCa.
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Assessment method [5]
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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.
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Timepoint [5]
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Within 7 days following randomisation and every 6 months ± 30 days after randomisation
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Secondary outcome [6]
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Number of biopsy cores
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Assessment method [6]
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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.
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Timepoint [6]
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Within 3 months following randomisation
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Secondary outcome [7]
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Incidence of complications following transperineal prostate biopsy.
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Assessment method [7]
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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.
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Timepoint [7]
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Within 7 days following randomisation and at 3 and 6 months after randomisation
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Secondary outcome [8]
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Incidence of erectile dysfunction following transperineal prostate biopsy
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Assessment method [8]
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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).
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Timepoint [8]
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Within 7 days following randomisation and at 3 and 6 months after randomisation
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Secondary outcome [9]
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Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2)
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Assessment method [9]
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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
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Timepoint [9]
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Within 28 days following randomisation
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2028
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Actual
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Sample size
Target
660
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Austin Health - Melbourne
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Recruitment hospital [6]
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Cabrini Health - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4006 - Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3084 - Melbourne
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Recruitment postcode(s) [6]
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3144 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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St Vincent's Hospital, Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
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Trial website
https://clinicaltrials.gov/study/NCT05154162
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Hofman
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gaurav Sharma
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Address
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Country
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Phone
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+61 3 8559 6830
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05154162