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

This study is currently recruiting participants.
Verified December 2016 by Therese Seierstad, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464216
First Posted: November 3, 2011
Last Update Posted: December 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Radboud University
Information provided by (Responsible Party):
Therese Seierstad, Oslo University Hospital
October 31, 2011
November 3, 2011
December 9, 2016
October 2011
December 2016   (Final data collection date for primary outcome measure)
Death [ Time Frame: 2030 ]
Not Provided
Complete list of historical versions of study NCT01464216 on ClinicalTrials.gov Archive Site
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MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood, bone marrow, lymph nodes, prostate tissue, urine
Non-Probability Sample
Prostate cancer patients referred for surgical treatment.
  • Prostatic Neoplasms
  • Genital Neoplasms, Male
  • Prostatic Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2030
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact: Therese Seierstad, PhD, MHA therese@radium.uio.no
Norway
 
 
NCT01464216
REK-2010/1656
No
Not Provided
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Therese Seierstad, Oslo University Hospital
Oslo University Hospital
Radboud University
Not Provided
Oslo University Hospital
December 2016