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Cell-derived vesicles as diagnostic instrument for prostate cancer.

Conditions
prostate cancer
Registration Number
NL-OMON28556
Lead Sponsor
Academisch Medisch Centrum Amsterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

Healthy volunteers:

Adult male not related to the Urology department ≤ 40 years old. Informed consent signed.

Exclusion Criteria

Healthy volunteers:

Clinical signs of prostate diseases, medical or surgical therapy for prostate disease.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the concentration of tdEVs in plasma and urine in PCa patients and assess whether a relationship exists to disease state.
Secondary Outcome Measures
NameTimeMethod
1.To determine whether (elevated levels of) prostate-derived EVs are detectable in plasma and/or urine samples from mCRPC patients compared to both healthy controls as well as controls with elevated PSA.<br /><br>2.To determine whether (elevated levels of) prostate-derived EVs are detectable in plasma and/or urine samples from early stage PCa patients to both healthy controls as well as controls with elevated PSA.<br /><br>3.To identify mRNAs that differentiate PCa from controls <br /><br>4.To assess whether a correlation exists between ctDNA, tdEV, mRNA.<br /><br>5.To verify that any PCa associated markers from secondary objectives 1-4 are reduced to approximately the control level after prostatectomy.
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