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Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Watchful Waiting
This study is currently recruiting participants.
Study NCT00796874   Information provided by National Cancer Institute (NCI)
First Received: November 21, 2008   Last Updated: June 9, 2009   History of Changes

November 21, 2008
June 9, 2009
October 2008
April 2013   (final data collection date for primary outcome measure)
Prostate cancer progression measured by MRI while on active surveillance [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796874 on ClinicalTrials.gov Archive Site
Prostate cancer changes by MRI [ Designated as safety issue: No ]
Same as current
 
Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Watchful Waiting
MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance

RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, watchful waiting may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed.

PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in detecting cancer progression in patients with early-stage prostate cancer who are undergoing watchful waiting.

OBJECTIVES:

Primary

  • To determine if MRI parameters (initial volume, number and location of image abnormalities, and MR spectroscopy) can improve the ability to stratify cancer progression risk in patients undergoing active surveillance for early-stage prostate cancer.

Secondary

  • Determine if changes in non-invasive MRI, validated by MRI-guided biopsies, can accurately detect progression of prostate cancer.

OUTLINE: Patients undergo prostate MRI scans and MRI-guided biopsies of suspicious lesions at baseline. Patients undergo conventional anatomic imaging followed by research biological imaging tests (e.g., magnetic resonance spectroscopic imaging and/or dynamic contrast-enhanced MRI). MRI are repeated at 6 months, 1 year, and then annually until initiation of definitive therapy or for a total of 5 years.

Tissue biopsy with MRI guidance is done at baseline and annually or as clinically indicated based on change in rectal exam, PSA, or maybe done based on change in MR imaging (i.e., new MR lesion or significant change [> 25% increase] in the size of a MR lesion).

Blood samples are collected at baseline and periodically during study for PSA tests.

 
Interventional
Diagnostic
Prostate Cancer
  • Other: imaging biomarker analysis
  • Procedure: biopsy
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
  • Procedure: magnetic resonance imaging
  • Procedure: magnetic resonance spectroscopic imaging
  • Procedure: observation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
April 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Low-risk for progression, as evidenced by all of the following:

    • Tumor stage ≤ T2a
    • PSA ≤ 10 ng/mL
    • Gleason score ≤ 7
  • Patients informed of treatment options and has already chosen to undergo active surveillance

    • No decision to stop active surveillance
  • No node-positive or metastatic disease

PATIENT CHARACTERISTICS:

  • Willing to undergo MRI
  • Willing to undergo prostate biopsy
  • No contraindications to MRI that include, but not limited to, any of the following:

    • Claustrophobia
    • Anxiety
    • Presence of metal or shrapnel in the body
    • Pacemakers
    • Old tattoos with metal-based dye material
  • No contraindication to prostate biopsy
  • No medical conditions, as deemed by the PI or associates, that would prevent or limit the patient participation on the protocol that include, but not limited to, any of the following:

    • Severe coagulopathy
    • History of severe bleeding
    • Severe coronary artery disease
    • Other comorbid conditions that limit life expectancy to less than 2 years

PRIOR CONCURRENT THERAPY:

  • No hormone therapy within the past year
  • No prior pelvic radiotherapy
  • No prior prostate resection including transurethral resection of prostate
  • Concurrent participation in other clinical studies (e.g., vitamin D, selenium) allowed provided active surveillance is continued
Male
18 Years and older
No
 
United States
 
NCT00796874
Anurag K. Singh, NCI - Radiation Oncology Branch; ROB
CDR0000618738, RPCI-I-124107
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP