Incorporation of Multimodality Magnetic Resonance Imaging in the PRIAS study

Incorporation of Multimodality Magnetic Resonance Imaging in the PRIAS study - MRI value in PRIAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33150

Enrollment

Registered

2009-08-07

Start date

2009-10-09

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histologically proven adenocarcinoma of the prostate • PSA

Exclusion criteria

Exclusion criteria: • Patients with known contradictions to MRI • Patients with known contra-indications to Gadolinium based contrast agents. • Patients with previous therapy for prostate cancer. • Patients who can not or do not want to receive curative treatment in form of radiotherapy or radical prostatectomy • Patient request for definitive curative intervention

Design outcomes

Primary

Measure	Time frame
The main study parameter is the number of patients with a positive difference in Gleason grade (upgrading) of follow-up MRGB versus inclusion TRUSGB (expected to be 22% or higher in first year of follow-up and hopefully lower at the end of the first year and in the fourth year of follow-up) versus the number of patients with a positive difference in Gleason grade (upgrading) of repeat TRUS-GB versus inclusion TRUS-GB (expected round 12% in first year of follow-up and hopefully lower at the end of the first year and in the fourth of follow-up). This maij study parameter will be determined at baseline ( 2 months), and at 1 and four years of follow-up.	—

Measure

Time frame

The main study parameter is the number of patients with a positive difference in Gleason grade (upgrading) of follow-up MRGB versus inclusion TRUSGB (expected to be 22% or higher in first year of follow-up and hopefully lower at the end of the first year and in the fourth year of follow-up) versus the number of patients with a positive difference in Gleason grade (upgrading) of repeat TRUS-GB versus inclusion TRUS-GB (expected round 12% in first year of follow-up and hopefully lower at the end of the first year and in the fourth of follow-up). This maij study parameter will be determined at baseline ( 2 months), and at 1 and four years of follow-up.

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Secondary

Measure	Time frame
Secondary study parameters include: The number of cancers included in the PRIAS study that are visible on MRI. The number of delayed interventions based on patient request after incorporation of MRI. Other study parameters are the mean progression free survival, the disease specific mortality and overall mortality, the incidence of (lymfogenic) metastasis in monitored population, the correlation of PCA3 values with progression of low-grade prostate cancer	—

Measure

Time frame

Secondary study parameters include: The number of cancers included in the PRIAS study that are visible on MRI. The number of delayed interventions based on patient request after incorporation of MRI. Other study parameters are the mean progression free survival, the disease specific mortality and overall mortality, the incidence of (lymfogenic) metastasis in monitored population, the correlation of PCA3 values with progression of low-grade prostate cancer

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Countries

Netherlands

Outcome results