Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00796874

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:

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer

U.S. FDA Resources

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 ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Correlative Study

Tissue Removal

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

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator:

Anurag K. Singh, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anurag K. Singh, 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:	February 24, 2011
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 February 09, 2012