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

This study is currently recruiting participants.
Verified October 2011 by Oslo University Hospital
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Therese Seierstad, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01464216
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Prostatic Neoplasms
Genital Neoplasms, Male
Prostatic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Biospecimen Retention:   Samples With DNA

Blood, bone marrow, lymph nodes, prostate tissue


Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prostate cancer patients referred for surgical treatment.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464216

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0310
Contact: Therese Seierstad, phD     +4746451987     Therese.Seierstad@rr-research.no    
Principal Investigator: Therese Seierstad, phD            
Principal Investigator: Knut Håkon Hole, MD            
Principal Investigator: Karol Axcrona, phD            
Sponsors and Collaborators
Oslo University Hospital
Radboud University
  More Information

No publications provided

Responsible Party: Therese Seierstad, Head of Research, Department of Radiology and Nuclear Medicine, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01464216     History of Changes
Other Study ID Numbers: REK-2010/1656
Study First Received: October 31, 2011
Last Updated: November 2, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Institutional Scientific Board

Keywords provided by Oslo University Hospital:
Functional Magnetic Resonance Imaging
Prostate cancer

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Prostatic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 16, 2013