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MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01464216
Acronym
FuncProst
Enrollment
120
Registered
2011-11-03
Start date
2011-10-31
Completion date
2030-12-31
Last updated
2022-06-21

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

Conditions

Genital Neoplasms, Male, Prostatic Diseases, Prostatic Neoplasms

Keywords

Functional Magnetic Resonance Imaging, Prostate cancer, FACBC PET, Hypoxia imaging

Brief summary

The purpose of the study is to combine and correlate data from morphological and functional MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.

Detailed description

A prospective study including 180 consecutive patients with PCa referred to Oslo University Hospital, Radiumhospitalet, for surgical treatment. In vivo functional MRI examination will be performed within a few days prior to robot-assisted radical prostatectomy (RALP). For a subgroup of patients FACBC PET will also be acquired prior to prostatectomy. A subgroup of intermediate and high-risk patients (D'Amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (Hypoxyprobe™-1)\*. During surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. High-risk patients will undergo intraoperative lymph node dissection. Tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. Prostate specimen and regional lymph nodes will be histopathologically examined for T- and N-classification, Gleason grade, presence of micrometastasis and areas of hypoxia. Histological and molecular findings will be correlated to MRI and PET findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death). \*From 2013 oral administration is used.

Interventions

None listed

Sponsors

Radboud University Medical Center
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* Patients suitable for surgery with confirmed prostate cancer, Gleason grade ≥ 3 * Patient has received no prior treatment for prostate cancer. * Patient has adequate renal function: Estimated creatinine clearance ≥ 60 ml/minute. * Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee.

Exclusion criteria

* Patient with contraindication to MR or MR contrast media according to clinical practice. * Patients who want to withdraw for any reason during the study. * Patients previously undergone pelvic surgery or radiation therapy

Design outcomes

Primary

MeasureTime frame
Death2030

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026