NCT06565247RecruitingPhase 3
Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate and compare the accuracy of PSMA-PET and mpMRI for identification and delineation of the most clinically relevant intra-prostatic lesions or sub-regions.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Dec 2023
- Start date
- 14 Oct 2024
- Lead sponsor
- Region Vasterbotten
- Diseases
- Prostate cancer
- EU CT number
- 2022-501892-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-MR-safe implants or another contraindication to MRI or PET
- Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)
- Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumor.
Other illness
- Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
Lab values
- Creatinine clearance < 30ml/min
Other
- Tinnitus or severe hearing loss
- Claustrophobia
- Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
- WHO PS >1
- TUR-P within 6 months
Who the study is looking for
- Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy
- PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer
- ≥4 weeks since last biopsy of the prostate
- One or more of the following criteria: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score ≥8 c) PSA 20-49 ng/ml
- >18 years
- Given a written consent to participate in the trial
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.