Evaluating imaging techniques for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.