New Markers for Treatment Response to Radiotherapy in Prostate Cancer

November 28, 2023 updated by: Cyrill Rentsch, University of Basel

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.

Study Overview

Status

Withdrawn

Conditions

Prostate Cancer

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- Basel-Stadt
  - Basel, Basel-Stadt, Switzerland, 4031
    - Department of Urology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Men undergoing definite radiotherapy for prostate cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bio-repository Time Frame: first assessment using predifined markers after recruitment of 15 patients followed for 1 year	first assessment using predifined markers after recruitment of 15 patients followed for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Investigators

Principal Investigator: Cyrill A Rentsch, MD-PhD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)