Tailored treatment of prostate cancer by biomarkers: PROCABIO

Completed

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

• Registration Number: NL-OMON33361
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients who decide to participate in PRIAS or are participating in PRIAS for less than 2 years are eligible. The inclusion criteria for PRIAS are the following:
1. Histologically proven adenocarcinoma of the prostate
2. Men should be fit for curative treatment
3. PSA-level at diagnosis <= 10 ng/mL
4. PSA density (PSA D) less than 0,2
5. Clinical stage T1C or T2
6. Adequate biopsy sampling (see 'biopsy protocol')
7. Gleason score 3+3=6
8. One or 2 biopsy cores invaded with prostate cancer
9. Participants must be willing to attend the follow-up visits

Exclusion Criteria

The exclusion criteria for PRIAS are the following:
1. Men who can not or do not want to be irradiated or operated
2. A former therapy for prostate cancer

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Results of the analysis of the candidate biomarkers in the appropriate type of<br /><br>sample in the patient sample sets from all clinical centres.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.a.</p><br>