Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation

Launched by REGION VÄSTERBOTTEN · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how certain imaging techniques, specifically PSMA-PET and mpMRI, can help doctors better understand and treat high-risk prostate cancer. The goal is to see how the images of the cancer relate to the actual tissue characteristics, which could lead to improved ways of diagnosing the disease and guiding treatment decisions.

Men aged 18 and older who have been confirmed to have prostate cancer and are planning to undergo surgery may be eligible to participate. To qualify, participants need to have had a PSMA-PET scan and meet at least one of the following criteria: signs of cancer growth beyond the prostate, a high Gleason score (which indicates aggressive cancer), or a specific level of prostate-specific antigen (PSA) in their blood. Participants will undergo imaging tests, which are a key part of the research, and will help doctors learn more about how to treat prostate cancer effectively. It's important to note that individuals with certain medical conditions or previous treatments may not be eligible for this trial.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
• • 2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.
• • 3. ≥4 weeks since last biopsy of the prostate
• • 4. One or more of the following criteria
• • 1. cT3, or high suspicion of extra prostatic growth on mpMRI
• • 2. Gleason score ≥8
• • 3. PSA 20-49 ng/ml
• • 5. \>18 years
• • 6. Given a written consent to participate in the trial
• Exclusion Criteria:
• • 1. Non-MR-safe implants or another contraindication to MRI or PET
• • 2. Claustrophobia
• • 3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
• • 4. WHO PS \>1
• • 5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
• • 6. TUR-P within 6 months
• • 7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
• • 8. 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 tumour.
• • 9. Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
• • 10. Tinnitus or severe hearing loss