ISRCTN ISRCTN37591328
DOI https://doi.org/10.1186/ISRCTN37591328
Secondary identifying numbers 1
Submission date
13/01/2020
Registration date
15/01/2020
Last edited
04/06/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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?
Prof. Dr. Peter Albers
Division of Personalized Early Detection of Prostate Cancer
German Cancer Research Center (DKFZ)
+49 6221 42-3046
p.albers@dkfz.de

Study website

Contact information

Mr Peter Albers
Scientific

Personalisierte Früherkennung des Prostatakarzinoms (C130)
Deutsches Krebsforschungszentrum
Im Neuenheimer Feld 581
Heidelberg
69120
Germany

ORCiD logoORCID ID 0000-0002-1747-9615
Phone +49 (0)6221 42-3046
Email p.albers@dkfz.de

Study information

Study designProspective multicenter randomized cohort study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleRisk-adapted prostate cancer (PCa) early detection study based on a “baseline” PSA value in young men – a prospective multicenter randomized trial (PROBASE)
Study acronymPROBASE
Study objectivesMen 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(s)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
Health condition(s) or problem(s) studiedProstate cancer
InterventionMen 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 typeOther
Primary outcome measureIncidence of metastatic prostate cancer up to the age of 60 as judged by imaging and confirmatory biopsy of metastases.
Secondary outcome measuresMeasured 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 study start date01/01/2013
Completion date30/04/2034

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit45 Years
SexMale
Target number of participants46,000
Key inclusion criteria1. 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
Key exclusion criteriaPrevious history of prostate cancer
Date of first enrolment01/02/2014
Date of final enrolment31/12/2019

Locations

Countries of recruitment

  • Germany

Study participating centres

University Hospital Dusseldorf
Department of Urology
Moorenstr. 5
Düsseldorf
40225
Germany
Hannover Medical School
Department of Urology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Heidelberg University Hospital
Department of Radiation Oncology
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Technical University of Munich
Department of Urology
Ismaninger Str. 22
Munich
81675
Germany

Sponsor information

German Cancer Aid
Charity

Postfach 1467
Bonn
53004
Germany

Phone +49 (0)228 72990207
Email deutsche@krebshilfe.de
Website http://www.krebshilfe.de/metanavigation/english.html
ROR logo "ROR" https://ror.org/01wxdd722

Funders

Funder type

Charity

Deutsche Krebshilfe
Private sector organisation / Other non-profit organizations
Alternative name(s)
Stiftung Deutsche Krebshilfe, German Cancer Aid
Location
Germany

Results and Publications

Intention to publish date31/05/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planIntend to publish main results and conclusions of the study.
Dissemination at congresses.
Relevant publications and magazines in public health and urology.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Interim results article 18/10/2023 23/10/2023 Yes No
Interim results article 01/06/2022 12/11/2024 Yes No
Interim results article 01/03/2024 12/11/2024 Yes No
Results article 01/12/2023 12/11/2024 Yes No
Other publications Worry about prostate cancer and risk perception 05/03/2025 19/05/2025 Yes No
Other publications Prostate Cancer Detection in Younger Men: A Comparative Analysis of Systematic and Magnetic Resonance Imaging-targeted Biopsy in the PROBASE Trial 02/06/2025 04/06/2025 Yes No

Editorial Notes

04/06/2025: Publication reference added.
19/05/2025: Publication reference added.
14/11/2024: The study participating centre Department at Heidelberg University Hospital was amended.
13/11/2024: The sponsor email was changed.
12/11/2024: Publication references added.
12/11/2024: Contact details updated.
23/10/2023: Publication reference added.
14/01/2020: Trial’s existence confirmed by Ethics committee at University Hospital Dusseldorf