Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 909 for:    Open Studies | "Prostatic Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 20, 2014
Last verified: October 2014
  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
Official Title: MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Death [ Time Frame: 2030 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, bone marrow, lymph nodes, prostate tissue


Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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). A subgroup of 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 findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: October 20, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on November 25, 2014