Prostate Cancer
Conditions
Keywords
prostate, prostate bed, periprostatic
Brief summary
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.
Detailed description
Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.
Interventions
OTHERObservation of transponder stability
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
Sponsors
Varian, a Siemens Healthineers Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma 2. Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse 3. Patients being planned for radiation therapy 4. Patient is being planned for implant with Calypso Transponders in the prostate bed 5. No evidence of distant metastases 6. Age ≥ 18 years 7. Informed consent
Exclusion criteria
1. The patient has received other investigational therapy in the last 60 days 2. The patient has previously been implanted with permanent beacon transponders 3. The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials 4. The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy | Immediate |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the stability of the Calypso transponder in the prostate bed | 60 days |
Countries
United States
Outcome results
None listed