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

Tracking Information
First Received Date ^ICMJE	October 31, 2011
Last Updated Date	November 2, 2011
Start Date ^ICMJE	October 2011
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01464216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Blood, bone marrow, lymph nodes, prostate tissue
Sampling Method	Non-Probability Sample
Study Population	Prostate cancer patients referred for surgical treatment.
Condition ^ICMJE	Prostatic Neoplasms Genital Neoplasms, Male Prostatic Diseases
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	180
Completion Date	Not Provided
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01464216
Other Study ID Numbers ^ICMJE	REK-2010/1656
Has Data Monitoring Committee	No
Responsible Party	Therese Seierstad, Oslo University Hospital
Study Sponsor ^ICMJE	Oslo University Hospital
Collaborators ^ICMJE	Radboud University
Investigators ^ICMJE	Not Provided
Information Provided By	Oslo University Hospital
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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