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.
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
Study summary
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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
Primary outcome measure(s)
Presence of sPCa on prostate biopsy — 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.
Number of men who avoid transperineal prostate biopsy in the experimental arm — 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
Trial sites (6)
Facility
City
Region
Status
St Vincent's Hospital
Sydney
New South Wales
Royal Brisbane and Women's Hospital
Brisbane
Queensland
Royal Adelaide Hospital
Adelaide
South Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
Austin Health
Melbourne
Victoria
Cabrini Health
Melbourne
Victoria
More Peter MacCallum Cancer Centre, Australia trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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