None listed
Conditions
Brief summary
Who is it for? You may be eligible to join this study if you are aged 18 years or above, male, and have a new diagnosis of prostate cancer that is being managed through active surveillance. Study details All participants in this study will undergo the usual monitoring processes of mpMRI and confirmatory biopsy. In addition, all participants will undergo one PSMA PET scan at the time of their repeat mpMRI, and, if applicable, one PSMA-targeted biopsy at time of their confirmatory biopsy. The repeat mpMRI and PSMA PET/CT will occur at Epworth Medical Imaging, Freemasons. The results of the scans and biopsies will be used by a panel of experts to make recommendations as to whether the participant should remain on active surveillance for their prostate cancer, or receive active treatment. It is hoped that this research will improve the accuracy of prostate cancer monitoring, and lead to better outcomes for patients who are in active surveillance.
Interventions
In addition to standard repeat mpMRI of the prostate, men on active surveillance for prostate cancer who are approaching their confirmatory prostate biopsy will also receive a Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET-CT) scan. Should the PSMA PET-CT scan demonstrate a lesion that was otherwise not detected by the mpMRI, an additional PSMA-targeted biopsy will be taken at the time of the confirmatory biopsy.
To prepare for the PSMA PET/CT scan
In addition to standard repeat mpMRI of the prostate, men on active surveillance for prostate cancer who are approaching their confirmatory prostate biopsy will also receive a Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET-CT) scan. Should the PSMA PET-CT scan demonstrate a lesion that was otherwise not detected by the mpMRI, an additional PSMA-targeted biopsy will be taken at the time of the confirmatory biopsy. To prepare for the PSMA PET/CT scan, the participant needs to receive an injection of a radioactive substance (18F-DCPyL) through their arm/hand vein. They will need to wait up to 1 hour for the radioactive substance to travel through their bloodstream before the actual scan takes place. The scan takes 20-30 minutes. The entire PSMA PET/CT procedure takes around 2-2.5 hours and can be completed in one visit and it can begin immediately following the MRI scan. The PSMA PET/CT and the repeat standard mpMRI both need to be completed between 3-6 months after the participant has been diagnosed with prostate cancer. All confirmatory biopsies (including the PSMA-targeted biopsy) will be carried out by the same urologist who took the initial diagnostic biopsy. All confirmatory biopsies will be taken within a single visit. The systematic and the mpMRI targeted biopsy are standard of care. The PSMA-targeted biopsy is only applicable if the PSMA PET/CT scans detect a new lesion. It would take no more than an additional 10 minutes to standard of care. The PSMA-targeted biopsy will occur no more than 3 months after the PSMA PET/CT scan. To monitor adherence, the study team will book all participants for their PSMA PET-CT at Epworth Freemasons. The study team will be in ongoing communication with the participants and their local urologists. After all of the scans (mpMRI and PSMA PET-CT) and confirmatory biopsies (systematic +/- MRI-targeted +/- PSMA-targeted) have been completed and reported, each case will be presented to a dedicated Epworth Uro-oncology multidisciplinary team. Initially only results from standard/current treatment will be shared. The panel of experts will then provide their recommendation as to whether the patient should remain on active surveillance for their prostate cancer, or receive active treatment (surgery or radiotherapy). Next, the results from the PSMA PET-CT scan and targeted biopsies will be shared with the panel. They then have the option to stick with their initial recommendation, or change it. The standard of care for prostate cancer patients on active surveillance is the repeat mpMRI and confirmatory biopsy (without the PSMA PET/CT scan and the PSMA-targeted biopsy). The panel's recommendation will be shared with the participant and their treating doctor
Sponsors
EJ Whitten Prostate Cancer Research Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any man, 18-years and over who has undergone prostate biopsy with a new diagnosis of prostate cancer, being managed through active surveillance, with one or more of the following 'high-risk features': - GG2 cancers where the amount of pattern 4 is 10% or less - GG1 cancers which are considered to be high volume - GG1 cancers that have PIRADS 4 or 5 lesion on the MRI - Low volume GG1 cancer but has a high PSA
Exclusion criteria
- A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer - A known history of prostate cancer - A diagnostic prostate biopsy of more than 6 months prior - Contra-indication to 3T mpMRI or PSMA PET/CT - Significant intercurrent morbidity limiting compliance with study protocols
Outcome results
None listed