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MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on 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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Prostate cancer progression measured by MRI while on active surveillance

Outcome Time Frame:

at 6 months, 1 year and than annualy for 5 years

Safety Issue:

No

Principal Investigator

Anurag K. Singh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000618738

NCT ID:

NCT00796874

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms
  • Neoplastic Processes

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263