The GÖTEBORG prostate cancer screening 2 trial

• Register: ISRCTN
• Last refreshed on: 9 January 2023
• Main ID: ISRCTN94604465
• Date of registration: 10/07/2017
• Prospective Registration: No
• Primary sponsor: University of Gothenburg
• Public title: The GÖTEBORG prostate cancer screening 2 trial
• Scientific title: The GÖTEBORG Prostate Cancer Screening 2 trial (G2): a prospective, randomized, large-scale, population-based prostate cancer screening trial using PSA followed by magnetic resonance imaging of the prostate
• Date of first enrolment: 01/09/2015
• Target sample size: 40000
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN94604465
• Study type: Interventional
• Study design: Population-based randomized controlled trial (Screening)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Jonas Hugosson

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male
2. Age 50-60
3. Living in selected municipalities in Västra Götaland, Sweden

Exclusion criteria: Men with prior diagnosis of prostate cancer

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate cancer
Cancer
Malignant neoplasm of prostate

Intervention(s)

By computerized randomization, a random sample of 40,000 men living in Västra Götalandsregionen will gradually be randomized and form the database. If a man decides to participate he visits a clinic to have a regular blood draw (PSA). The analysis of PSA is carried out at a central lab. Men who choose to participate are randomized, by blinded computer randomization, in a 1:1:1 ratio (equal sizes) into three different screening strategies:

Arm 1: Reference arm: PSA cut-off 3 ng/mL, standard biopsies for all men with PSA >=3 plus targeted biopsies for MR+
“Screen-negative”: If the Total-PSA level is “normal”, i.e. below 3.0 ng/mL, no further testing or examination will be performed but all men will be re-invited (see below).
“Screen-positive”: If the PSA level is “elevated” above the cut-off i.e. 3.0 ng/mL, the man will be invited for a multi-parametric MRI (mpMRI). Irrespective of the MRI result all men will be recommended “STANDARD BIOPSY”, i.e. digital rectal exam followed by TRUS-guided 10-core standard prostate biopsy according to the screening protocol (as is also clinical practice). These standard biopsies will be taken blindly to the MRI result. During the same investigation after the standard biopsies the urologist will be shown the result from MRI and in case of a suspicious lesion at MRI also targeted biopsies (4 cores) will be added (same procedure as in the performed pilot study. The results from the reference arm could be divided into those detected by standard biopsy alone (pure PSA detected – common practice today) and those also detected by targeted biopsies (false negatives).

Arm 2: Experimental arm I: PSA cut-off 3 ng/mL, only targeted biopsies for MR+
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Primary Outcome(s)

Rate of overdiagnosis, measured by linking the study population/study database with the Regional Cancer Registry every third month until the study ends

Secondary Outcome(s)

Rate of prostate biopsy, defined as the number of events per randomized men measured continuously throughout the study

Tertiary outcome measure:
Prostate cancer mortality, measured by linkage with the Swedish Causes of Death Registry twice a year until the study ends

Secondary ID(s)

N/A

Source(s) of Monetary Support

Cancerfonden, Swedish Government, Biocare, Regional Cancer Center West, Vetenskapsrådet

Ethics review

Status:
Approval date:
Contact:

Regional Ethical Review Board, 28/01/2015, ref: 890-14

Results

• Results available: Yes
• Date Completed: 31/12/2040