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

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ClinicalTrials.gov Identifier: NCT01464216
Recruitment Status : Recruiting
First Posted : November 3, 2011
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
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
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness
Study Start Date : October 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Death [ Time Frame: 2030 ]

Biospecimen Retention:   Samples With DNA
Blood, bone marrow, lymph nodes, prostate tissue, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464216


Contacts
Contact: Therese Seierstad, PhD, MHA therese@radium.uio.no

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

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
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016

Keywords provided by Therese Seierstad, Oslo University Hospital:
Functional Magnetic Resonance Imaging
Prostate cancer
FACBC PET
Hypoxia imaging

Additional relevant MeSH terms:
Prostatic Diseases
Prostatic Neoplasms
Neoplasms
Hypoxia
Aggression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Signs and Symptoms, Respiratory
Signs and Symptoms
Behavioral Symptoms