Prostate Cancer
Conditions
Brief summary
A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.
Interventions
DEVICECeevra Reveal
3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.
Sponsors
Ceevra, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is undergoing robotic prostatectomy being performed by participating surgeon * Patient is willing to be randomized between intervention and control arms
Exclusion criteria
* Patients with prior pelvic radiation * Patients with prior androgen deprivation therapy * Patients with prior localized ablative therapy * Patients with prior TURP or other surgical BPH treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative PSA | Up to 24 months | PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Margin Status | Immediately postoperatively | Defined as positive or negative surgical margin |
| Androgen Deprivation or Radiation Therapy | Up to 24 months postoperatively | Any occurrence of salvage or adjuvant therapy post surgery |
| Postoperative Erectile Function | Up to 24 months postoperatively | Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months |
| Postoperative Urinary Function | Up to 24 months postoperatively | Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months |
Countries
United States
Outcome results
None listed