MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

NCT ID: NCT01464216

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2030-12-31

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.

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Prostatic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Therese Seierstad

Head of Research, Department of Radiology and Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

REK-2010/1656

Identifier Type: -

Identifier Source: org_study_id