Prostate CancerSPROUTNCT07180381
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
A study testing PSA and MRI-monitoring in people with Prostate Cancer, run by St. Antonius Hospital at 7 sites in Netherlands.
Trial summary
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,. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA and MRI-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 7 sitesNetherlands
- Study dates
- 14 May 2025to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland
Laura S Mertens, MD PhD, 0205129111, l.mertens@nki.nl
- Recruiting
Andros Clinics
Arnhem, Gelderland, 6842 CV
Paul J.M. Kil, MD PhD, 026 389 1753, p.kil@andros.nl
- Recruiting
Treant
Emmen, Drenthe, 7824AA
Luc A.J. Roelofs, MD, PhD, +310881290147, l.roelofs@treant.nl
- Recruiting
St Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Vera Sweere, MD, 0031612138028, v.sweere@antoniusziekenhuis.nl
Harm H.E. Van Melick, MD PhD, 00316683201444, h.van.melick@antoniusziekenhuis.nl
- Recruiting
Radboud University Medical Centre
Nijmegen, Gelderland, 6525 GA
Toine G van der Heijden, MD PhD, 024361 38 03, toine.vanderheijden@radboudumc.nl
- Recruiting
Canisius Wilhelmina Hospital
Nijmegen, Gelderland
Rik M Somford, MD PhD, 024 365 8255, r.somford@cwz.nl
- Not yet recruiting
Maasstad Hospital
Rotterdam, South Holland
Roderick C.N. van den Bergh, MD PhD, 0102912265, BerghR@maasstadziekenhuis.nl
About this study
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
- Prostate Cancer
- Being tested
- PSA and MRI-monitoring
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA and MRI-monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually. Receives: Other: PSA and MRI-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 months
Number of negative biopsies
Number of participants with negative biopsy results during the study including findings from the end of study biopsies.
Measured: 48 months
Secondary outcomes (5)
Grade shifts
Progression rates of intermediate- to high-risk group during monitoring, rates of downgrading from intermediate risk to low risk
Measured: 48 months
Detection of very high risk prostate cancer
Detection of very high risk prostate cancer (ISUP GG ≥ 3) during the study, including end of study biopsies.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start14 May 2025
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 503 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harm H.E. Van Melick, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180381
- Sponsor's protocol ID
- NL-005445
- Acronym
- SPROUT
- Status last verified
- Nov 2025
- First submitted
- 16 Jul 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42242939
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
- ClinicalTrials.gov ID
- NCT07180381
- Acronym / sponsor ID
- SPROUT / NL-005445
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 503 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Other: PSA and MRI-monitoringParticipants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA and MRI-monitoringMen 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. | Other | Study arm |
Primary outcome
Proportion clinically significant prostate cancer missed during follow up
Time frame: 48 months
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.
Number of clinically insignificant prostate cancer detected
Time frame: 48 months
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.
Number of negative biopsies
Time frame: 48 months
Number of participants with negative biopsy results during the study including findings from the end of study biopsies.
5 secondary outcomes
Grade shifts
Time frame: 48 months
Detection of very high risk prostate cancer
Time frame: 48 months
Health-related quality of life (EPIC-26 score)
Time frame: 48 months
Estimated average cost per patient during 48-month follow-up
Time frame: 48 months
Anxiety symptomes (STAI-6 score)
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 42242939Sweere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA and MRI-monitoring in people with Prostate Cancer, run by St. Antonius Hospital at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion clinically significant prostate cancer missed during follow up (time frame: 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.