Prostate cancer Cancer Prostate cancer
Conditions
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
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
| Measure | Time frame |
|---|---|
| Incidence of metastatic prostate cancer up to the age of 60 years as judged by imaging and confirmatory biopsy of metastases | — |
Secondary
| Measure | Time 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