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Trial Title: MRI in Diagnosing Prostate Cancer

NCT ID: NCT01292291

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Primary purpose: Diagnostic

Intervention:

Intervention type: Other
Intervention name: biologic sample preservation procedure

Intervention type: Other
Intervention name: laboratory biomarker analysis

Intervention type: Other
Intervention name: study of socioeconomic and demographic variables

Intervention type: Procedure
Intervention name: diffusion-weighted magnetic resonance imaging

Intervention type: Procedure
Intervention name: dynamic contrast-enhanced magnetic resonance imaging

Intervention type: Procedure
Intervention name: multiparametric magnetic resonance imaging

Intervention type: Procedure
Intervention name: quality-of-life assessment

Intervention type: Procedure
Intervention name: transperineal prostate biopsy

Intervention type: Procedure
Intervention name: transrectal prostate biopsy

Intervention type: Procedure
Intervention name: ultrasound-guided prostate biopsy

Summary: RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease. PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.

Detailed description: OBJECTIVES: - To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy. - To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy. - To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway. OUTLINE: This is a multicenter study. Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy. Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis. Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness. After completion of study intervention, patients are followed up periodically.

Criteria for eligibility:
Criteria:
DISEASE CHARACTERISTICS: - Men at risk of prostate cancer who have been advised to have a prostate biopsy - Suspected stage ≤ T2 on rectal examination (organ confined) - Serum PSA ≤ 15 ng/mL within the past 3 months PATIENT CHARACTERISTICS: - Fit for general/spinal anesthesia - Fit to undergo all protocol procedures including a transrectal ultrasound - No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months - No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50) - No other medical condition precluding procedures described in the protocol PRIOR CONCURRENT THERAPY: - No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable) - No prior hip replacement surgery

Gender: Male

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: April 2011

Lead sponsor:
Agency: University College London Hospitals
Agency class: Other

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01292291

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