Condition category
Cancer
Date applied
13/01/2020
Date assigned
15/01/2020
Last edited
15/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prostate cancer is the most commonly diagnosed cancer accounting for approximately 60,000 new cases every year in Germany. However, it is only the third common cause of death from cancer. The widespread use of PSA as screening method for prostate cancer has led to an increased incidence of prostate cancer which is accompanied by a shift towards earlier stages of detected cancers. With respect to the demographic changes in industrialized countries the incidence of prostate cancer will continue to increase.
The aim of the present trial is to demonstrate the superiority of a delayed risk-adapted screening beginning at age 50 (study arm B) as compared to a risk-adapted PSA screening beginning at age 45 with respect to the specificity of the screening.

Who can participate?
Healthy male volunteers aged 45 at the time of entering the study, with no history of prostate cancer.

What does the study involve?
Participants will be randomly allocated to receive their initial prostate cancer screening blood test, called a prostate-specific antigen (PSA) test at age 45 or age 60. Participants will be followed up and provide samples at two or five yearly intervals depending on the results of the screening.

What are the possible benefits and risks of participating?
Benefits are the delay of the start of a screening program with reduction of worries, unnecessary diagnostics like biopsies without harm because the detection of cancers 5 years later is not expected to lead to any risk.
The risk of the participation is to be randomized to the deferred PSA screening arm with a potentially late diagnosis of aggressive prostate cancer.

Where is the study run from?
1. University Hospital Dusseldorf, Germany
2. Hannover Medical School, Germany
3. Heidelberg University Hospital, Germany
4. Technical University of Munich, Germany

When is the study starting and how long is it expected to run for?
February 2014 to April 2034

Who is funding the study?
Deutsche Krebshilfe (German Cancer Aid)

Who is the main contact?
Mr Peter Albers
Peter.Albers@med.uni-duesseldorf.de

Trial website

https://www.probase.de/

Contact information

Type

Scientific

Primary contact

Mr Peter Albers

ORCID ID

http://orcid.org/0000-0002-1747-9615

Contact details

Department of Urology
University Hospital Düsseldorf
Moorenstr. 5
Düsseldorf
40225
Germany
+49 (0)2118118110
Peter.Albers@med.uni-duesseldorf.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Risk-adapted prostate cancer (PCa) early detection study based on a “baseline” PSA value in young men – a prospective multicenter randomized trial (PROBASE)

Acronym

PROBASE

Study hypothesis

Men undergoing a risk-adapted PSA screening at age 50 do not more frequently develop metastatic disease up to the age of 60 as compared to those men beginning a risk-adapted PSA screening at age 45

Ethics approval

1. Approved 11/07/2013, Ethics committee at University Hospital Dusseldorf (40204 Düsseldorf, Germany; +49 (0)211 8119591; Ethikkommission@med.uni-duesseldorf.de), ref: 4257
2. Approved 25/09/2013, Ethics committee at Hannover Medical School (30623 Hannover, Germany; ; no tel. provided; Ethikkommission@mh-hannover.de), ref: 1989-2013
3. Approved 12/08/2013, Ethics committee at University Hospital Heidelberg (Alte Glockengießerei11/1, 69115 Heidelberg, Germany; no tel. provided; Ethikkommission-l@med.uni-heidelberg.de), ref: S-425/2013
4. Approved 16/09/2013, Ethics committee at Technical University of Munich (Ismaninger Staße 22, 81675 München, Germany; no tel. provided; Info@ek.med.tum.de), ref: 5911/13

Study design

Prospective multicenter randomized cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Prostate cancer

Intervention

Men at age 45 are randomized into two screening groups following a 1:1 distribution for early first PSA (prostate specific antigen) testing at age 45 (study arm A) versus delayed first PSA testing at age 50 (study arm B). To balance group sizes and to minimize selection bias between study sites a permuted-block randomization will be used. No stratification is designated.

According to the individual level of the baseline PSA value subjects of both screening groups will be submitted to the same risk-adapted screening intervals.

Subjects with a baseline PSA value <1.5 ng/ml undergo 5-yearly screening intervals as long as the PSA value remains <1.5 ng/ml in the following screening rounds.

Subjects with a baseline PSA value of 1.5-2.99 ng/ml undergo 2-yearly screening intervals.

Subjects having or exceeding the cut-off PSA value of 3.0 ng/ml at baseline or in one of the following screening rounds will be submitted to a multiparametric magnetic resonance imaging (MRI) and to a stereotactically-guided targeted biopsy combined with a random biopsy of the prostate.

Complete recruitment of the study will be finished within 5 years. Thus, the whole study duration including 15 years of screening and follow-up is estimated to be 20 years (without data cleaning and write up).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Incidence of metastatic prostate cancer up to the age of 60 as judged by imaging and confirmatory biopsy of metastases.

Secondary outcome measures

Measured by patient records:
1. Incidence of late metastasis (M+ = radiographically and histologically proven bone metastases and/or radiographically and histologically proven nonregional lymph node or visceral metastases) after curative treatment (radical prostatectomy, radiotherapy) of detected prostate cancers up to the age of 60
2. Incidence of biochemical recurrences after curative treatment (radical prostatectomy, radiotherapy) of detected prostate cancers up to the age of 60
3. Locally advanced prostate cancers detected up to the age of 60
4. Incidence of high-grade prostate cancers detected up to the age of 60
5. The prostate cancer mortality rate up to the age of 60
6. Overall survival up to the age of 60

Overall trial start date

01/01/2013

Overall trial end date

30/04/2034

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males at age 45 at the time of consent
2. Willing and able to provide written informed consent
3. Written data protection consent has been obtained
4. Able to adhere to the study visit schedule and requirements of the protocol

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

46,000

Participant exclusion criteria

Previous history of prostate cancer

Recruitment start date

01/02/2014

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Dusseldorf
Department of Urology Moorenstr. 5
Düsseldorf
40225
Germany

Trial participating centre

Hannover Medical School
Department of Urology Carl-Neuberg-Str. 1
Hannover
30625
Germany

Trial participating centre

Heidelberg University Hospital
Department of Urology Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Trial participating centre

Technical University of Munich
Department of Urology Ismaninger Str. 22
Munich
81675
Germany

Sponsor information

Organisation

German Cancer Aid

Sponsor details

Postfach 1467
Bonn
53004
Germany
+49 (0)228 72990207
Gregory@krebshilfe.de

Sponsor type

Charity

Website

http://www.krebshilfe.de/metanavigation/english.html

Funders

Funder type

Charity

Funder name

Deutsche Krebshilfe

Alternative name(s)

German Cancer Aid

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Germany

Results and Publications

Publication and dissemination plan

Intend to publish main results and conclusions of the study.
Dissemination at congresses.
Relevant publications and magazines in public health and urology.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/05/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/01/2020: Trial’s existence confirmed by Ethics committee at University Hospital Dusseldorf