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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA and MRI-monitoring | Other | Men with PI-RADS 3 or 4 lesions and a PSA density ≤ 0.15 ng/mL² are actively monitored with PSA testing every six months and MRI annually, instead of undergoing immediate prostate biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion clinically significant prostate cancer missed during follow up | 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. | 48 months |
| Number of clinically insignificant prostate cancer detected | Detection of clinically insignificant prostate cancer (International Society of Urological Pathology Grade Group (ISUP GG) 1) during the 48 months of follow up compared to the total ISUP GG 1 including end of study biopsies. | 48 months |
| Number of negative biopsies | Number of participants with negative biopsy results during the study including findings from the end of study biopsies. | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grade shifts | Progression rates of intermediate- to high-risk group during monitoring, rates of downgrading from intermediate risk to low risk | 48 months |
| Detection of very high risk prostate cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Treant | Recruiting | Emmen | Drenthe | 7824AA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42242939 | Derived | Sweere 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. |
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Detection of very high risk prostate cancer (ISUP GG ≥ 3) during the study, including end of study biopsies.
| 48 months |
| Health-related quality of life (EPIC-26 score) | Change in health-related quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire with subscales ranging from 0 to 100. Higher scores indicate better function and less symptom burden. Although the diagnosis of prostate cancer is not confirmed, this is the best validated and suitable questionnaire. Participants will be asked to fill in the questionnaire once a year. | 48 months |
| Estimated average cost per patient during 48-month follow-up | Mean cost per participant over 48 months, including diagnostics (e.g. MRI, biopsies), consultations, and treatments, based on predefined unit costs and healthcare utilization. | 48 months |
| Anxiety symptomes (STAI-6 score) | Change in anxiety levels as measured by the 6-item short form of the State-Trait Anxiety Inventory (STAI-6), with scores ranging from 20 to 80. Higher scores indicate greater anxiety. Participants will be asked to fill in the questionnaire once a year. | 48 months |
| Andros Clinics | Recruiting | Arnhem | Gelderland | 6842 CV | Netherlands |
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| Radboud University Medical Centre | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| Canisius Wilhelmina Hospital | Recruiting | Nijmegen | Gelderland | Netherlands |
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| Antoni van Leeuwenhoek Hospital | Recruiting | Amsterdam | North Holland | Netherlands |
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| Maasstad Hospital | Not yet recruiting | Rotterdam | South Holland | Netherlands |
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| St Antonius Hospital | Recruiting | Nieuwegein | Utrecht | 3435 CM | Netherlands |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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