NCT01464216

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
55mo left

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2011Dec 2030

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

11.2 years

First QC Date

October 31, 2011

Last Update Submit

June 16, 2022

Conditions

Prostatic NeoplasmsGenital Neoplasms, MaleProstatic Diseases

Keywords

Functional Magnetic Resonance ImagingProstate cancerFACBC PETHypoxia imaging

Outcome Measures

Primary Outcomes (1)

  • Death

    2030

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer patients referred for surgical treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0310, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow, lymph nodes, prostate tissue, urine

MeSH Terms

Conditions

Prostatic NeoplasmsGenital Neoplasms, MaleProstatic Diseases

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Department of Radiology and Nuclear Medicine

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2030

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

NO(1)