Circulating PSA-containing macrophages: a tool to distinguish indolent from aggressive prostate cancer? A pilot study.

Completed

• Conditions: prostate cancer; prostate carcinoma; 10038588; 10036958

• Registration Number: NL-OMON33803
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Men >= 18 years
- Histological confirmed adenocarcinoma of the prostate
- Localized prostate cancer
- Scheduled for radical prostatectomy
- Given informed consent

Exclusion Criteria

- Metastatic disease
- Patient not able to understand the patient information

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in the number of activated PSA positive macrophages<br /><br>(preoperatively) between patients with significant and insignificant cancers<br /><br>(insignificant defined as < 0.5 ml of cancer, no Gleason pattern 4 or 5, no<br /><br>extraprostatic extension, no seminal vesicle invasion, no lymph node metastasis<br /><br>and absence of positive surgical margins).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The difference in the number of activated PSA positive macrophages (at 1<br /><br>week, 6 weeks and 6 months postoperatively) between patients with significant<br /><br>and insignificant cancers.<br /><br><br /><br>- The difference in the number of activated PSA positive macrophages<br /><br>(preoperatively, or at 1 week, 6 weeks, 6 months postoperatively) between<br /><br>patients with biochemical recurrence (serum PSA at 3 months and 1 year<br /><br>postoperatively > 0.2 ng/ml)</p><br>