Pilot study: performance of the Progensa PCA3 test in post-oxytocin urine specimens - Pilot: Progensa PCA3 test in post-oxytocin urine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024649-61-NL

Enrollment

Registered

2011-01-11

Start date

2011-04-05

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer trial: intended indication for product is to mobilize prostate cells in urethra for PCA3 test. MedDRA version: 12.1 Level: PT Classification code 10033329 Term: Oxytocin

Interventions

Product Name: oxytocin Product Code: RVG03716 Pharmaceutical Form: Nasal spray*

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: healthy male adult volunteers, =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026