MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Sponsors

Lead Sponsor: Oslo University Hospital

Collaborator: Radboud University

Source Oslo University Hospital
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.

Overall Status Recruiting
Start Date 2011-10-01
Completion Date 2030-12-01
Primary Completion Date 2016-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
Death 2030
Enrollment 180
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

Male

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Therese Seierstad, PhD, MHA

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Oslo University Hospital Therese Seierstad, phD +4746451987 [email protected] Therese Seierstad, phD Principal Investigator Knut Håkon Hole, MD Principal Investigator Karol Axcrona, phD Principal Investigator
Location Countries

Norway

Verification Date

2016-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oslo University Hospital

Investigator Full Name: Therese Seierstad

Investigator Title: Head of Research, Department of Radiology and Nuclear Medicine

Keywords
Has Expanded Access No
Condition Browse
Acronym FuncProst
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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