FuncProst: MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Sponsor

Oslo University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01464216

Collaborator

Radboud University Medical Center (Other)

120

Enrollment

Location

230

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Genital Neoplasms, Male 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 Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

Death [2030]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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