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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00796874 |
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.
Condition | Intervention |
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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 |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance |
Estimated Enrollment: | 100 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Low-risk for progression, as evidenced by all of the following:
Patients informed of treatment options and has already chosen to undergo active surveillance
PATIENT CHARACTERISTICS:
No contraindications to MRI that include, but not limited to, any of the following:
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:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 |
Principal Investigator: | Anurag K. Singh, MD | Roswell Park Cancer Institute |
Responsible Party: | NCI - Radiation Oncology Branch; ROB ( Anurag K. Singh ) |
Study ID Numbers: | CDR0000618738, RPCI-I-124107 |
Study First Received: | November 21, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00796874 History of Changes |
Health Authority: | Unspecified |
stage I prostate cancer stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |