Clinical trial NCT01464216: MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
Official title: MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostatic Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Keywords: Functional Magnetic Resonance Imaging
Prostate cancer
FACBC PET
Hypoxia imaging
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2011-11-03
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients referred for surgical treatment.

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.

Eligibility 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

Primary outcomes:
measure: Death
timeFrame: 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: