Evaluating imaging techniques for high-risk prostate cancer
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
PHASE3 · Region Västerbotten · NCT06565247
This study is testing whether new imaging techniques can help doctors better understand and treat high-risk prostate cancer in patients preparing for surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Region Västerbotten (other gov) |
| Locations | 2 sites (Malmö and 1 other locations) |
| Trial ID | NCT06565247 on ClinicalTrials.gov |
What this trial studies
This trial investigates the relationship between imaging properties from PSMA-PET and mpMRI and tissue characteristics through histopathological validation in patients with high-risk prostate cancer. It is an open, non-randomized, prospective multi-center trial conducted at Skåne University Hospital and Umeå University Hospital, focusing on improving diagnostic accuracy and treatment guidance. Patients with histologically confirmed prostate cancer who are scheduled for radical prostatectomy will be recruited consecutively for this study.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with high-risk prostate cancer, specifically those with certain clinical and histopathological criteria.
Not a fit: Patients with contraindications to MRI or PET, claustrophobia, or those with metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnostics and improve treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for prostate cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Malmö and 1 other locations
- Region Skåne — Malmö, Sweden (RECRUITING)
- Region Västerbotten — Umeå, Sweden (RECRUITING)
Study contacts
- Principal investigator: Camilla Thellenberg Karlsson, MD, PhD — Region Västerbotten
- Study coordinator: Camilla Thellenberg Karlsson, MD, PhD
- Email: camilla.thellenberg@umu.se
- Phone: +46907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer