EUCTR2020-001387-28-NL
Active, Not Recruiting
Phase 1
18F-PSMA-1007 PET to detect primary prostate cancer: a comparative study with mpMRI and correlation to histopathology.
Conditions75 patients with the suspicion on PCa (elevated PSA and/or abnormal digital rectal exam) will receive a PSMA-PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this explorative study.MedDRA version: 20.0Level: LLTClassification code 10036921Term: Prostate carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 75 patients with the suspicion on PCa (elevated PSA and/or abnormal digital rectal exam) will receive a PSMA-PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this explorative study.
- Sponsor
- Radboud University Medical Center
- Enrollment
- 75
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
- •\- Males \= 18 years
- •\- ECOG 0\-1
- •\- Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 25
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
Exclusion Criteria
- •\- Prostate biopsy in the last 6 months
- •\- History of prostate cancer
- •\- Second active malignancy
- •\- Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
- •\- Any medical condition that in the opinion of the investigator will affect patients’ clinical status when participating in this trial.
- •\- Contra\-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.
Outcomes
Primary Outcomes
Not specified
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