Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validatio
- Conditions
- Prostate cancerMedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
- Registration Number
- CTIS2022-501892-14-00
- Lead Sponsor
- Region Vasterbotten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 20
Histologically confirmed high-risk 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: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score =8 c) PSA 20-49 ng/ml, >18 years, Given a written consent to participate in the trial
Non-MR-safe implants or another contraindication to MRI or PET, Tinnitus or severe hearing loss, 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 such 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 tumor., Creatinine clearance < 30ml/min
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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