MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

NCT03225222 | Completed

• 1 other identifier: OZBS92.16132
• Study Type: observational
• Target: 2,558
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

Conditions

Prostate Cancer

Keywords

Prostate cancer; multivariate risk assessment; MRI; biopsy; screening; multicenter

Outcome Measures

Primary Outcomes (1)

• Proportion of detected csPCa

  Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway

  36 months

Secondary Outcomes (3)

• Number of biopsy procedures in relation to detected csPCa.

  36 months

• Proportion of unnecessary TRUS-guided and targeted biopsies

  36 months

• CEA Risk stratification-MRI

  36 months

Study Arms (4)

Low-risk PCa

No TRUS-guided biopsy

Intermediate/high-risk PCa (Control)

TRUS-guided biopsy 'only' (current standard practice).

Diagnostic Test: biopsy

Intermediate/high-risk PCa (Intervention 1)

TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies.

Diagnostic Test: biopsy

Intermediate/high-risk PCa (Intervention 2)

MRI-'first', followed by TRUS-guided and targeted biopsies.

Diagnostic Test: biopsy

Interventions

biopsy DIAGNOSTIC_TEST

prostate biopsy

Intermediate/high-risk PCa (Control); Intermediate/high-risk PCa (Intervention 1); Intermediate/high-risk PCa (Intervention 2)

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men are eligible for the study if there is a clinical suspicion of harbouring prostate cancer without previous prostate biopsies. This essentially includes men with an elevated PSA (≥ 3 ng/ml) and/or a suspicious DRE, or family history of prostate cancer.

You may qualify if:

• men ≥ 50 years,
• no prior prostate biopsies,
• suspected of having prostate cancer based on PSA blood test (≥ 3 ng/ml) and/or DRE( digital rectal examination) and/or family history of prostate cancer,
• fit to undergo all protocol procedures,
• signed informed consent.

You may not qualify if:

• contra-indications to MRI or TRUS biopsy procedures,
• any medical condition precluding procedures described in the protocol

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmusmc

Rotterdam, South Holland, 3015CE, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ivo Schoots, Dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 21, 2017
• Study Start: November 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

NL (1)