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Analysis of the performance of PSMA emission tomography in patients with prostate cancer treated with HIFU
EU CTIS ID: 2026-525181-22-00
What this study is testing
The objective of this pilot study is to conduct an initial assessment of the diagnostic performance of PSMA PET/CT in diagnosing prostate cancer recurrence at 1-year follow-up in patients with favourable intermediate-risk localised prostate cancer treated with HIFU as a first-line curative therapy. The gold standard for diagnosis is biopsy at 1 year.
- Therapeutic use (Phase IV)
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
- Patient with prostate cancer
- Age ≥ 70 years
- Life expectancy > 5 years
- Clinical data - Clinical stage T1c – T2a - PSA < 20 ng/ml
- Biopsy data - Unilateral ISUP 2 in a maximum of 2 contiguous sextants with or without ipsilateral or contralateral ISUP 1 focus - Single focus or multiple foci if only one ISUP 2 focus in the targeted biopsy
- Imaging data - Single lesion - PIRADS 3 or 4 or 5 - Prostate volume < 150 ml
You likely can't join if
- Presence of signs of extraprostatic extension or invasion of the seminal vesicles
- Patients deprived of their liberty or under legal protection (guardianship and trusteeship, judicial protection)
- Any condition that, in the investigators' judgement, would interfere with the subject's ability to provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results
- Hypersensitivity to the active substances or to any of the excipients of the investigational medicinal product 18F-PSMA
- Contraindications to magnetic resonance imaging (MRI), such as the presence of internal metal devices
- Chronic kidney disease with an eGFR ≤ 60 mL/min
See the full eligibility criteria
- Patient with prostate cancer
- Age ≥ 70 years
- Life expectancy > 5 years
- Clinical data - Clinical stage T1c – T2a - PSA < 20 ng/ml
- Biopsy data - Unilateral ISUP 2 in a maximum of 2 contiguous sextants with or without ipsilateral or contralateral ISUP 1 focus - Single focus or multiple foci if only one ISUP 2 focus in the targeted biopsy
- Imaging data - Single lesion - PIRADS 3 or 4 or 5 - Prostate volume < 150 ml
- Affiliated with a social security scheme
- Fair and informed consent signature
- Presence of signs of extraprostatic extension or invasion of the seminal vesicles
- Patients deprived of their liberty or under legal protection (guardianship and trusteeship, judicial protection)
- Any condition that, in the investigators' judgement, would interfere with the subject's ability to provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results
- Hypersensitivity to the active substances or to any of the excipients of the investigational medicinal product 18F-PSMA
- Contraindications to magnetic resonance imaging (MRI), such as the presence of internal metal devices
- Chronic kidney disease with an eGFR ≤ 60 mL/min
- Liver failure
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, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
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.