MRI/MRSI in Risk Assessment of Prostate Cancer Patients

NCT00582543 | Completed

• 1 other identifier: 05-113
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and radio waves to take pictures of body structure (MRI) and to measure amounts of important chemicals within the body (MRSI). This study will look at the structural and chemical properties of prostates before undergoing treatment. Hopefully, doctors will be able to use this method before making treatment decisions for patients with newly diagnosed cancer of the prostate. This study will continue our work to assess the value of MRI/MRSI in addressing what is currently one of the greatest clinical challenges in the management of prostate cancer: the identification of low-risk organ-confined prostate cancer that can be managed expectantly with deferred treatment.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostate

Outcome Measures

Primary Outcomes (1)

• In a population of patients designated as clinically indolent by NCCN guidelines, we will evaluate the ability of eMRI/MRSI to predict pathologically indolent cancer. eMRI/MRSI findings will be compared with step-section pathology.

  October 2010

Secondary Outcomes (2)

• In the patients who are identified as harboring indolent prostate cancer by both clinical guidelines and eMRI/MRSI, clinical progression of disease will be evaluated in a cohort of patients receiving deferred therapy.

  October 2010

• We will explore whether eMRI/MRSI markers of progression correlate with clinical markers of progression.

  October 2010

Study Arms (1)

eMRI/MRSI

EXPERIMENTAL

Patients will undergo eMRI/MRSI examination. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position.

Other: eMRI/MRSI

Interventions

eMRI/MRSI OTHER

Patients will undergo eMRI/MRSI examination. All subjects will be asked to administer a Fleet enema on the day of the study in order to reduce the potential for fecal residue to interfere with imaging acquisition and quality. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position. The entire eMRI/MRSI study will be performed within 55-60 minutes.

Also known as: All patients enrolled in the protocol will have clinically indolent disease as, defined by NCCN guidelines. Treatment selection between definitive treatment, and deferred therapy will be decided jointly by the patient and the treating, physician (non-randomized selection). Patients will be treated with radical, prostatectomy (RP) or radiation therapy (RT) or will be placed on deferred, therapy.

eMRI/MRSI

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer
• Clinically low-risk localized disease as defined by NCCN guidelines (clinical stage T1-T2a, maximum Gleason score 2-6, peak serum PSA level \< 10 ng/ml)
• No evidence of disseminated disease (bone or lymph node metastases)
• Treatment-radical prostatectomy, radiation therapy, or deferred therapy-will be at MSKCC
• Willingness to undergo serial surveillance TRUS-guided prostate biopsies and eMRI/MRSI examination at MSKCC if placed on deferred therapy protocol
• In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six months of eMRI/MRSI study

You may not qualify if:

• Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery)
• Inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status
• Presence of known contraindication to eMRI
• Unwillingness or inability to undergo placement of endorectal MR coil or ultrasound probe. As is the case for a standard MR exam, the presence of a pacemaker or aneurysm clips could pose a risk to patients, making them unable to have an eMRI, and therefore unable to participate in this study.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Physicians; Prostatectomy; Radiotherapy; Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hedvig Hricak, M.D., Ph.D

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: October 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

US (1)