MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness (FuncProst)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Genital Neoplasms, Male; Prostatic Neoplasms; Prostatic Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0310
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients referred for surgical treatment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death	2030

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Prostate cancer; Functional Magnetic Resonance Imaging; Hypoxia imaging; FACBC PET
• Additional Relevant MeSH Terms: Behavioral Symptoms; Urogenital Neoplasms; Neoplasms by Site; Signs and Symptoms, Respiratory; Aggression; Neoplasms; Prostatic Neoplasms; Hypoxia; Prostatic Diseases; Genital Neoplasms, Male
• Other Study ID Numbers: REK-2010/1656