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Clinical use of [18F]florastamine PET/CT in patients with PI-RADS≤3 report of multi-parametric MRI and suspected prostate cancer
EU CTIS ID: 2023-510421-14-00
What this study is testing
To analyse the sensitivity of florastamin (18F) PET/CT in localisation of csPCa in patients with elevated serum PSA levels and/or PSA density and with clinical suspicion of PCa and with report of PI-RADS v2.1.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male gender
- Age ≥18 years
- PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2
- PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion
- Availability of mpMRI data for centralized reading
- Patient scheduled for biopsy or radical prostatectomy
You likely can't join if
- Absence of any of the inclusion criteria
- Androgen deprivation therapy or any targeted treatment for PCa prior florastamin (18F) PET/CT.
- Hypersensitivity to active substance or any of excipients of investigational medicinal product
- Life expectancy <6 months
- ECOG performance status >2
- Concomitant active malignancy and/or confirmed metastases
See the full eligibility criteria
- Male gender
- Age ≥18 years
- PSA ≥10ng/mL and/or PSAD≥0.26 ng/mL2
- PI-RADS v2 ≤3 report of mpMRI performed less than 3 months prior inclusion
- Availability of mpMRI data for centralized reading
- Patient scheduled for biopsy or radical prostatectomy
- Signed informed consent
- Absence of any of the inclusion criteria
- Androgen deprivation therapy or any targeted treatment for PCa prior florastamin (18F) PET/CT.
- Hypersensitivity to active substance or any of excipients of investigational medicinal product
- Life expectancy <6 months
- ECOG performance status >2
- Concomitant active malignancy and/or confirmed metastases
- Past history of confirmed prostate cancer.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.