18F-PSMA PET in primary prostate cancer.

Phase 1

• 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.; 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]

• Registration Number: EUCTR2020-001387-28-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 75

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified