New Markers for Treatment Response to Radiotherapy in Pro... | NCT06159998

Studies
New Markers for Treatment Response to Radiotherapy in Prostate Cancer

NCT06159998

Sponsor

University of Basel

Status

Withdrawn

Last Update Posted

Dec 7, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
180/09	Other Identifier	EKBB

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed

Expanded Access Info

Start Date

Jul 2009Actual

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2019Actual

First Submitted Date

Dec 11, 2012

First Submission Date that Met QC Criteria

Nov 28, 2023

First Posted Date

Dec 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Dec 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Men undergoing definite radiotherapy for prostate cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cyrill A Rentsch, MD-PhD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided