Last reviewed · How we verify
Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
NA trial testing Uronav guided biopsy in Prostate Cancer in 5 participants. Completed in 11 February 2018.
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 5 |
| Start date | 21 July 2016 |
| Primary completion | 25 January 2018 |
| Estimated completion | 11 February 2018 |
| Sites | 1 location across United States |
Case Comprehensive Cancer Center — full company profile →
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 2 |
Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 2 |
Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 1 |
Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 2 |
The infection rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of infection compared to standard transrectal biopsies .
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 0 |
The hospitalization rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of hospitalization compared to standard transrectal biopsies .
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 0 |
The study will be to report the incidence of successful completion of the transperineal biopsy procedure using the Uronav system which is provided by Philips Medical as part of the support for this study
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 5 |
Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 95.75 | ± 0.03 |
Dosimetric coverage of brachytherapy implant described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the post-implant prostate volume (given as a percent of the RX dose)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 111.63 | ± 0.07 |
post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 99.48 | ± 0.01 |
Dosimetric coverage of target lesion described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the targeted lesion volume (given as a percent of the RX dose)
| Group | Value | 95% CI |
|---|---|---|
| Uronav | 160.83 | ± 0.13 |
Time frame: Patients were be followed for safety assessments at post-operative day 1, and at 2 weeks post, 1 month post, and 3 months post. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Uronav |
|---|---|---|
| Sepsis | Infections and infestations | — |
| Reaction | System | Uronav |
|---|---|---|
| Nocturia | Renal and urinary disorders | — |
| Cystitis noninfective | Renal and urinary disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Erectile dysfunction | Reproductive system and breast disorders | — |
| Hypertension | Vascular disorders | — |
Most-reported serious reactions: Sepsis.
Data from ClinicalTrials.gov NCT02681614 adverse events section.
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).
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02681614.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing