NCT06159998

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

December 11, 2012

Last Update Submit

November 28, 2023

Conditions

Keywords

radiotherapymarkers

Outcome Measures

Primary Outcomes (1)

  • Bio-repository

    first assessment using predifined markers after recruitment of 15 patients followed for 1 year

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men undergoing definite radiotherapy for prostate cancer.

You may qualify if:

  • All patients undergoing radiotherapy of biopsy confirmed clinically localised adenocarcinoma of the prostate

You may not qualify if:

  • patients with inflammatory processes of the rectum
  • patients with no rectum due to previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

* PBMCs * Sera * Urine * prostate cells in urine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Cyrill A Rentsch, MD-PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD-PhD

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 7, 2023

Study Start

July 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2019

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations