Clinical trial · Interventional
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
NCT07180381CI-TRIAL-00098397SPROUTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,. The main questions it aims to answer are: * Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed? * Does it reduce unnecessary biopsies and overtreatment?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSA and MRI-monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually.
- interventionNames
- Other: PSA and MRI-monitoring
Primary outcomes (3)
- measure
- Proportion clinically significant prostate cancer missed during follow up
- timeFrame
- 48 months
- description
- Detection percentage of International Society of Urological Pathology Grade Group (ISUP GG)≥ 2 prostate cancer (= clinically significant prostate cancer) during 48 months of follow up compared with the percentage of total ISUP GG≥ 2 during the study, including any findings from end of study biopsies. ISUP grade groups range from 1 to 5, and a ISUP GG≥ 2 is defined as clinically significant prostate cancer.
- measure
- Number of clinically insignificant prostate cancer detected
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy \> 10 years * initial PSA \< 20 ng/ml * No signs of extracapsular disease on digital rectal examination * Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\< 0.15 * Mentally competent and able to comprehend the potential benefits and burdens of the study * Willing to undergo the follow-up protocol for a maximum of four years * written and signed informed consent Exclusion Criteria: * Men who have previously undergone a prostate biopsy * Men who have a prior PCa diagnosis * using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors * Proven germline mutation for PCa (for example: BRCA1; BRCA2) * Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion. * severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)
References
Publications (1)
- DERIVEDSweere V, de Rooij M, Kil PJM, Israel B, van Basten JPA, Boellaard TN, Graus SA, van der Heijden AG, van der Hoeven EJRJ, Klaver OS, Mertens LS, Prette JF, Roelofs LAJ, Sedelaar JPM, Snoek AM, Somford DM, Barentsz JO, Van Melick HHE, van den Bergh RCN. Sequential Imaging of Suspicion of Prostate Cancer: Reducing Overdiagnosis and Unnecessary Biopsy with Timely Diagnosis of Significant Cancer (SPROUT)-Prospective Multicentre Cohort Study Protocol. Eur Urol Oncol. 2026 Jun 4:S2588-9311(26)00153-7. doi: 10.1016/j.euo.2026.05.013. Online ahead of print. PMID 42242939