Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management

Summary

1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more accurate sampling of the tumors and therefore will increase the rate of "progression" on early (first and second) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided biopsies.
2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies.
3. Biomarker expression levels will correlate with biopsy progression.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

PROCEDURE

Transrectal Ultrasound-Guided Biopsy

Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).

PROCEDURE

MRI Ultrasound Biopsy

MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)

BEHAVIORAL

Expanded Prostate Cancer index Composite Questionnaire

Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy

BEHAVIORAL

Short-Form 12 of Health Related Quality of Life Questionnaire

Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy

BEHAVIORAL

Memorial Anxiety Scale for Prostate Cancer

Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy

PROCEDURE

Plasma/Serum Sample for biomarkers

Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)

PROCEDURE

Urine Sample for Biomarkers

Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)

PROCEDURE

Blood Tests for Blood Urea Nitrogen and Creatinine

Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse

PROCEDURE

Blood Test for Serum PSA

Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.

Sponsors & Collaborators

• University of Miami

  lead OTHER

Principal Investigators

• Dipen Parekh, MD · University of Miami

• Alan Pollack, MD · University of Miami

• Sanoj Punnen, MD · University of Miami

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2018-08-31

Countries

• United States

Study Locations