prostate cancer
Conditions
Interventions
n.a.
Sponsors
Academisch Medisch Centrum Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Healthy volunteers: Adult male not related to the Urology department ≤ 40 years old. Informed consent signed. Elevated PSA level: Patients presenting with a PSA level ≥ 3.0 ng/mL Informed consent signed. Before/after prostatectomy: Patients with localized PCa after prostate biopsy, who are planned for radical prostatectomy. Informed consent signed. mCRPC: Patients with histologically confirmed prostate cancer that is metastatic and progressing despite castrate levels of testosterone (<50 ng/mL). Informed consent signed.
Exclusion criteria
Exclusion criteria: Healthy volunteers: Clinical signs of prostate diseases, medical or surgical therapy for prostate disease. Elevated PSA level: No history or presence of cancers, or non-prostate urological disorders. Before/after prostatectomy: None. mCRPC: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the concentration of tdEVs in plasma and urine in PCa patients and assess whether a relationship exists to disease state. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. 3. To identify mRNAs that differentiate PCa from controls 4. To assess whether a correlation exists between ctDNA, tdEV, mRNA. 5. To verify that any PCa associated markers from secondary objectives 1-4 are reduced to approximately the control level after prostatectomy. | — |
Contacts
Public ContactT.M. de Reijke
Outcome results
None listed