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NCT Number: NCT07180381

Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

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?

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Treant, Emmen, Drenthe, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Grade shifts

    Time frame: 48 months

    Progression rates of intermediate- to high-risk group during monitoring, rates of downgrading from intermediate risk to low risk

  2. Detection of very high risk prostate cancer

    Time frame: 48 months

    Detection of very high risk prostate cancer (ISUP GG ≥ 3) during the study, including end of study biopsies.

  3. Health-related quality of life (EPIC-26 score)

    Time frame: 48 months

    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.

  4. Estimated average cost per patient during 48-month follow-up

    Time frame: 48 months

    Mean cost per participant over 48 months, including diagnostics (e.g. MRI, biopsies), consultations, and treatments, based on predefined unit costs and healthcare utilization.

  5. Anxiety symptomes (STAI-6 score)

    Time frame: 48 months

    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.

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: SPROUT

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Sep 18, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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