Pilot study: performance of the Progensa PCA3 test in post-oxytocin urine specimens - Pilot: Progensa PCA3 test in post-oxytocin urine
Phase 1
- Conditions
- Healthy volunteer trial: intended indication for product is to mobilize prostate cells in urethra for PCA3 test.MedDRA version: 12.1Level: PTClassification code 10033329Term: Oxytocin
- Registration Number
- EUCTR2010-024649-61-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
healthy male adult volunteers, <45 yrs old.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
(prostate) cancer, family history of prostate cancer, known PSA >3.0, medication that influence PSA level (eg finasteride, dutasteride), symptoms of urinary tract infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the yield of prostate cells in the urine specimen after oxytocin nasal spray, using a urine specimen with no manipulation as a reference method.;Secondary Objective: The secondary objective is to determine the PCA3 scores in the urine specimen after oxytocin nasal spray and the urine specimen with no manipulation.;Primary end point(s): The main study end point is to determine yield of prostate cells in the urine specimen collected after the oxytocin administration, compared to the yield in the spontaneous urine specimen without oxytocin administration.
- Secondary Outcome Measures
Name Time Method