Sequential imaging for suspicion of Prostate cancer Reducing Overdiagnosis and Unnecessary biopsy with Timely diagnosis of significant cancer

Sequential imaging for suspicion of Prostate cancer Reducing Overdiagnosis and Unnecessary biopsy with Timely diagnosis of significant cancer - SPROUT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57300

Enrollment

503

Registered

2024-10-22

Start date

2025-05-14

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

prostate cancer

Interventions

Biannual PSA test and annual MRI prostate. After 48 months end-of-study biopsies in case there is still a visible lesion on MRI.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Men aged > 18 years old - Life expectancy > 10 years - iPSA = 3 lesion)

Exclusion criteria

Exclusion criteria: - Men who have previously undergone a prostate biopsy - Men who have a prior PCa diagnosis - Not fulfilling inclusion criteria - Using any (anti-)hormonal therapy, including 5-alpha reductase inhibitors - Identified germline mutation associated with an increased risk of prostate cancer (e.g., in BRCA1 or BRCA2 genes - Secondary malignancy, besides basal cell carcinoma of the skin, for which the patient is receiving active treatment at the time of inclusion - Severe claustrophobia or other conditions that make MRI unsuitable (e.g., metal implants, pacemakers, or other metal-containing devices in the body)

Design outcomes

Primary

Measure	Time frame
Safety endpoint (non-inferiority): Detection percentage of ISUP GG >=2 PCa during 48 months of follow up compared with the percentage of total ISUP GG >=2 PCa detected during the study, including findings from end-of-study biopsies. Effectiveness endpoints: Detection of ISUP GG =1 and negative biopsy rates during 48 months of follow up compared to total ISUP GG =1 and negative biopsy rates including those obtained from end-of-study biopsy; prostate biopsy rates during the study compared to total number of prostate biopsies including end-of-study biopsies.	—

Measure

Time frame

Safety endpoint (non-inferiority): Detection percentage of ISUP GG >=2 PCa during 48 months of follow up compared with the percentage of total ISUP GG >=2 PCa detected during the study, including findings from end-of-study biopsies. Effectiveness endpoints: Detection of ISUP GG =1 and negative biopsy rates during 48 months of follow up compared to total ISUP GG =1 and negative biopsy rates including those obtained from end-of-study biopsy; prostate biopsy rates during the study compared to total number of prostate biopsies including end-of-study biopsies.

—

Secondary

Measure	Time frame
Cost-effectiveness: MRI-, complication-, outpatient consultation- and treatment rates. Health-related quality of life evaluated by questionnaires (EPIC-26 en 6-item short STAI). Upgrading and downgrading rates of MRI lesions.	—

Countries

Netherlands

Contacts

Public ContactV Sweere

St. Antonius Ziekenhuis

v.sweere@antoniusziekenhuis.nl088 320 25 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)