Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06565247

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

Led by Region Västerbotten · Updated on 2025-03-04

60

Participants Needed

2

Research Sites

372 weeks

Total Duration

On this page

Sponsors

R

Region Västerbotten

Lead Sponsor

U

Umeå University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
  • PSMA-PET/CT conducted as part of clinical management for existing prostate cancer
  • At least 4 weeks since last prostate biopsy
  • One or more of the following: clinical stage T3 or high suspicion of extra-prostatic growth on mpMRI, Gleason score 8 or higher, PSA 20-49 ng/ml
  • Older than 18 years
  • Provided written consent to participate in the trial
Not Eligible

You will not qualify if you...

  • Non-MR-safe implants or any contraindication to MRI or PET
  • Claustrophobia
  • Unfit for MRI or PET/MRI examination for any reason such as back pain
  • WHO performance status greater than 1
  • Treated with neoadjuvant or concomitant anti-testosterone therapy
  • Transurethral resection of the prostate (TUR-P) within 6 months
  • Metastatic disease outside the pelvis in skeleton, organs, or lymph nodes
  • Previous diagnosis of other malignant disease except basal cell carcinoma of skin or tumor free for at least 10 years
  • Creatinine clearance below 30 ml/min
  • Tinnitus or severe hearing loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Region Skåne

Malmö, Sweden

Actively Recruiting

2

Region Västerbotten

Umeå, Sweden

Actively Recruiting

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Research Team

C

Camilla Thellenberg Karlsson, MD, PhD

CONTACT

T

Tufve Nyholm, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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