The diagnostic potential of tumor derived extracellular vesicles (tdEVs) in plasma and urine of prostate cancer patients and healthy volunteers: pilot study.

Recruiting

Conditions: Prostate cancer - Prostate carcinoma
10027656

Registration Number: NL-OMON46711

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Healthy volunteers (N=10):
Adult male not related to the Urology department <= 40 years old.
Informed consent signed.;Elevated PSA level (N=40):
Patients presenting with a PSA level >= 3.0 ng/mL.
Informed consent signed.;Before/after prostatectomy (N=10):
Patients with localized PCa after prostate biopsy, who are planned for radical prostatectomy.
Informed consent signed.;mCRPC (N=10):
Patients with histologically confirmed prostate cancer that is metastatic and progressing despite castrate levels of testosterone (<50 ng/mL).
Informed consent signed.

Exclusion Criteria

Healthy volunteers:
Clinical signs of prostate diseases, no medical or surgical therapy for prostate disease.;Elevated PSA level:
Patients with a history or presence of other cancers, or non-prostate urological disorders.;Before/after prostatectomy:
None. ;mCRPC:
None.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the number of tdEVs, the ctDNA, and the unique mRNA<br /><br>reads in plasma and urine from PCa patients, measured once without follow-up<br /><br>for all participants except the prostatectomy patients where it will be<br /><br>measured at most three times (confirmation of elevated PSA, before and after<br /><br>prostatectomy).</p><br>

Secondary Outcome Measures