Infrared Spectroscopy of Exprimate Urine and Blood for Prostate Cancer Detectio

Recruiting

• Conditions: C61; N40; Malignant neoplasm of prostate; Hyperplasia of prostate

• Registration Number: DRKS00025319
• Lead Sponsor: udwig-Maxilians-Universität München, Fakultät für Physik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 750

Inclusion Criteria

All participants must fulfil all of the inclusion criteria and none of the exclusion criteria.
1) Ability to consent to this study; participant has consented to participation in this study
2) Willingness to fill in the study questionnaire
3) Age = 50 years
4) Belonging to one of the following three groups:
o Random male patients with histopathologically proven prostate cancer (PCa), without any prior malignancy or cancer therapy within two years before study inclusion
o Random male patients with benign prostate hyperplasia (BPH) and a negative digital-rectal examination of the prostate
o Self-reported healthy and non-symptomatic patients (healthy controls”) without PCa or a BPH and with relevant blood and urine values within the normal range and a negative digital-rectal examination of the prostate

Exclusion Criteria

1) Multiple cancers at present
2) History of cancer or cancer therapy within the last two years before enrolment
3) HIV, HCV, and HBV infections; acute infection
4) Any condition preventing blood-draw or exprimate urine donation; incompletely filled plasma tube
5) Any Vaccination (e.g. for SARS-CoV-2 or Influenza) within 14 days before study inclusion

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficiency of binary classification of combined plasma-exprimate urine IMFs is higher than the efficiency of binary classification based on any of the two single media (plasma or exprimate urine) IMFs.

Secondary Outcome Measures

Name	Time	Method
1. IMF information from the blood plasma combined with IMF information from the exprimate urine (combined plasma-exprimate urine IMFs”) provides higher efficiency of prostate cancer detection than analysis of any of the two single media.<br>2. Combined plasma-exprimate urine IMFs of the group of patients with prostate cancer and the combined IMFs from the group of individuals with benign prostate hyperplasia are significantly different and facilitate efficient binary classification;<br>3. Combined plasma-exprimate urine IMFs between subgroups of patients with prostate cancer will be different between each other e.g. patients of different stages (according to TNM staging);<br>4. Combined plasma-exprimate urine IMFs are experimentally reproducible, i.e. IMF variation of repeated measurements of the same sample will be smaller than inter- and intra-personal variation and mean difference will be > 0.8 STD (standard deviation).