Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study. Uronav system is an investigational device that is used on this study to help place markers in the patient. These are called fiducial markers and they are placed in the patient to help plan radiation treatment. Radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study. This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).

Key facts

Study ID

NCT02681614

Run by

Case Comprehensive Cancer Center

People needed

5

Starts

2016-07-21

Expected to finish

2018-02-11

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histopathology confirmed prostate cancer that is Gleason score ≤7(4+3) clinical stage ≤ T2bN0M0 with a Prostate-specific antigen (PSA) below 15 ng/mL.
• Patients must have MRI findings reporting intraprostatic lesions suspicious for malignancy.
• Patient must not have had any prior treatment for prostate cancer
• Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
• Subjects must have an International Prostate Symptom Score of ≤ 15.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Gleason score of ≥ 8(4+4)
• PSA ≥ 15 ng/mL.
• Clinical stage >T2b or evidence of nodal
• Patients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstruction.
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the unlikely risk of prostate cancer being life threatening in this population.

Where it is running

• Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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