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

St. Antonius Hospital503 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

503

Conditions

Prostate Cancer

Interventions

PSA and MRI-monitoringOTHER

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (7)

Treant

Emmen, Drenthe, Netherlands

RECRUITING

Andros Clinics

Arnhem, Gelderland, Netherlands

RECRUITING

Radboud University Medical Centre

Nijmegen, Gelderland, 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, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 48 months

Number of negative biopsies

Number of participants with negative biopsy results during the study including findings from the end of study biopsies.

Time frame: 48 months

Secondary Outcomes

Grade shifts

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 48 months