Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
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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 |
- 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 ]
- 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) |
-
Other: active surveillance
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 |
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| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | Anurag K. Singh, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
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 May 16, 2013