N/A
N=5
Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02681614 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Uronav guided biopsy (Device); Magnetic resonance imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI |
2 | — |
| PRIMARY Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI |
2 | — |
| PRIMARY Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI |
1 | — |
| PRIMARY Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI |
2 | — |
| SECONDARY Number of Participants With Infections Within 30 Days |
— | — |
| SECONDARY Number of Hospitalizations Within 30 Days |
— | — |
| SECONDARY Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure |
5 | — |
| SECONDARY Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume) |
95.75 | — |
| SECONDARY Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx) |
111.63 | — |
| SECONDARY Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume) |
99.48 | — |
| SECONDARY Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx) |
160.83 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02681614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.