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

NCT07180381 | Recruiting

• 1 other identifier: NL-005445
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 7

Brief 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,. 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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Grade shifts

  48 months

• Detection of very high risk prostate cancer

  48 months

• Health-related quality of life (EPIC-26 score)

  48 months

• Estimated average cost per patient during 48-month follow-up

  48 months

• Anxiety symptomes (STAI-6 score)

  48 months

Study Arms (1)

Study arm

EXPERIMENTAL

Participants will not undergo immediate prostate biopsy but will be monitored with PSA testing every six months and prostate MRI annually.

Other: PSA and MRI-monitoring

Interventions

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.

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (7)

Treant

Emmen, Drenthe, 7824AA, Netherlands

RECRUITING

Andros Clinics

Arnhem, Gelderland, 6842 CV, Netherlands

RECRUITING

Radboud University Medical Centre

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

RECRUITING

Antoni van Leeuwenhoek Hospital

Amsterdam, North Holland, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, South Holland, Netherlands

NOT YET RECRUITING

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: September 18, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)