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NCT Number: NCT06565247

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

In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Region Skåne, Malmö, Sweden

Loading trial locations.

About this study

Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.

High-risk prostate cancer patients referred for radical prostatectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed 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
  • cT3, or high suspicion of extra prostatic growth on mpMRI
  • Gleason score ≥8
  • PSA 20-49 ng/ml
  • >18 years
  • Given a written consent to participate in the trial

Exclusion criteria

  • Non-MR-safe implants or another contraindication to MRI or PET
  • Claustrophobia
  • Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
  • WHO PS >1
  • Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
  • TUR-P within 6 months
  • Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
  • 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.
  • Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
  • Tinnitus or severe hearing loss

Treatment and study plan

[18F]PSMA-PET

Drug

Pre-surgical imaging using [18F]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.

MRI sequences optimized for prostate cancer examinations

Device

T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital

Primary outcomes

  1. Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions

    Time frame: Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology

    Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Thellenberg Karlsson, MD, PhD

CONTACT

[email protected]

+46907850000

Tufve Nyholm, PhD

CONTACT

[email protected]

+46907850000

Sponsors and collaborators

Lead sponsor

Region Västerbotten

Other Gov

Collaborators

  • Lund University
  • Region Skane
  • Umeå University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Aug 21, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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