Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance

This study has been withdrawn prior to enrollment.
(PI decided to terminate study.)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00796874
First received: November 21, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance 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 active surveillance.


Condition Intervention
Prostate Cancer
Other: active surveillance
Other: imaging biomarker analysis
Procedure: biopsy
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Prostate cancer progression measured by MRI while on active surveillance [ Time Frame: at 6 months, 1 year and than annualy for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate cancer changes by MRI [ Time Frame: At 6months, 1 year and annually for 5 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: active surveillance
    Correlative Study
    Other: imaging biomarker analysis
    Correlative Study
    Procedure: biopsy
    Tissue Removal
    Procedure: dynamic contrast-enhanced magnetic resonance imaging
    Radiolical Medical Imaging
    Procedure: magnetic resonance imaging
    Radiolical Medical Imaging
    Procedure: magnetic resonance spectroscopic imaging
    Radiolical Medical Imaging
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796874

Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00796874     History of Changes
Other Study ID Numbers: CDR0000618738, RPCI-I-124107
Study First Received: November 21, 2008
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplastic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014