Early vs. delayed screening for prostate cancer
| ISRCTN | ISRCTN37591328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37591328 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1 |
| Sponsor | German Cancer Aid |
| Funder | Deutsche Krebshilfe |
- 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
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
Contact information
Scientific
Personalisierte Früherkennung des Prostatakarzinoms (C130)
Deutsches Krebsforschungszentrum
Im Neuenheimer Feld 581
Heidelberg
69120
Germany
 ORCID ID |
0000-0002-1747-9615 |
|---|---|
| Phone | +49 (0)6221 42-3046 |
| p.albers@dkfz.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective multicenter randomized cohort study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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) |
| Study acronym | PROBASE |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Incidence of metastatic prostate cancer up to the age of 60 as judged by imaging and confirmatory biopsy of metastases. |
| Key secondary outcome measure(s) |
Measured by patient records: |
| Completion date | 30/04/2034 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Sex | Male |
| Target sample size at registration | 46000 |
| Key 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 |
| Key exclusion criteria | Previous history of prostate cancer |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Germany
Study participating centres
Moorenstr. 5
Düsseldorf
40225
Germany
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Ismaninger Str. 22
Munich
81675
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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? |
|---|---|---|---|---|---|
| Results article | 01/12/2023 | 12/11/2024 | Yes | No | |
| 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 | |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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
