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Early vs delayed screening for prostate cancer

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37591328
Enrollment
46000
Registered
2020-01-15
Start date
2014-02-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate cancer

Interventions

Men at age 45 years are randomized into two screening groups following a 1:1 distribution for early first PSA (prostate specific antigen) testing at age 45 years (study arm A) versus delayed first PSA

Sponsors

German Cancer Aid
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Males at age 45 years 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

Exclusion criteria

Exclusion criteria: Previous history of prostate cancer

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 years 2. Incidence of biochemical recurrences after curative treatment (radical prostatectomy, radiotherapy) of detected prostate cancers up to the age of 60 years 3. Locally advanced prostate cancers detected up to the age of 60 years 4. Incidence of high-grade prostate cancers detected up to the age of 60 years 5. The prostate cancer mortality rate up to the age of 60 years 6. Overall survival up to the age of 60 years

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026