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

NCT ID: NCT00796874

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

active surveillance

Correlative Study

Intervention Type: OTHER

imaging biomarker analysis

Correlative Study

Intervention Type: OTHER

biopsy

Tissue Removal

Intervention Type: PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Radiolical Medical Imaging

Intervention Type: PROCEDURE

magnetic resonance imaging

Radiolical Medical Imaging

Intervention Type: PROCEDURE

magnetic resonance spectroscopic imaging

Radiolical Medical Imaging

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag K. Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Other Identifiers

RPCI-I-124107

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000618738

Identifier Type: -

Identifier Source: org_study_id