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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06159998
Other study ID # EKBB 180/09
Secondary ID 180/09
Status Withdrawn
Phase
First received
Last updated
Start date July 2009
Est. completion date July 2019

Study information

Verified date November 2023
Source University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The actual follow-up of patients undergoing definite radiotherapy for prostate cancer includes regular measurements of prostate specific antigen (PSA). Successful radiotherapy is critically dependent on local control of cancer; however, PSA takes 2-3 years to reach a nadir after therapy. We aim at collecting blood/urine after prostate massage before, and after radiotherapy in order to define new markers predicting local control earlier and more precisely than PSA.


Description:

Patients will be closely followed for 5 years (weeks 0, 2, 4, 6, and months 2, 3, 6, 9, 12, 18, 24, and then yearly). Each assessment includes PSA measurement, urine collection after prostatic massage, and blood collection.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2019
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - All patients undergoing radiotherapy of biopsy confirmed clinically localised adenocarcinoma of the prostate Exclusion Criteria: - patients with inflammatory processes of the rectum - patients with no rectum due to previous surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Department of Urology, University Hospital Basel Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bio-repository first assessment using predifined markers after recruitment of 15 patients followed for 1 year
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