MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
Conditions
Prostatic Neoplasms - Genital Neoplasms, Male - Prostatic Diseases
Conditions: official terms
Aggression - Genital Neoplasms, Male - Neoplasms - Prostatic Diseases - Prostatic Neoplasms
Conditions: Keywords
Functional Magnetic Resonance Imaging, Prostate cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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). A subgroup of 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 findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Male
Criteria: 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
Location
Oslo University Hospital
Oslo, Norway
Status: Recruiting
Contact: Therese Seierstad, phD - +4746451987 - Therese.Seierstad@rr-research.no
Start Date
October 2011
Completion Date
December 2030
Sponsors
Oslo University Hospital
Source
Oslo University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page