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Quantitative mpMRI to predict metastatic potential of prostate cancer

Quantitative mpMRI to predict metastatic potential of prostate cancer - QmpMRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51200
Enrollment
30
Registered
2021-12-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-04-15

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

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically proven primary cancer of the prostate, based on prostate biopsy-core analysis. - Patient is scheduled and fit for PSMA-PET/CT - Age*50 years. Ability to give voluntary written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: - Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators). - Prior prostate cancer treatment. - Prior pelvic surgery, associated with pelvic lymphadenopathy - Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients* clinical status by participating in this trial. - Inability to lie still for 45 minutes or comply with imaging. - The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.

Design outcomes

Primary

MeasureTime frame
The main parameter of this study is the feasibility of MRI, as a weighted score of combined quantitative MRI parameters, to predict the presence of lymph node metastases in prostate cancer.

Secondary

MeasureTime frame
Secondary endpoints comprise established thresholds in individual quantitative MRI parameters separating localized from (oligo-)metastatic disease.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)