Prostate CancerNCT00763152
CMT-07-08: The PROstate Bed Evaluation Study
An observational study of Prostate Cancer, run by Varian, a Siemens Healthineers Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Observation of transponder stability
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer of the peri-prostatic tissue or prostate bed
Who may be able to join
- Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma
- Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
- Patients being planned for radiation therapy
- Patient is being planned for implant with Calypso Transponders in the prostate bed
- No evidence of distant metastases
- Age ≥ 18 years
- Informed consent
Who cannot join
- The patient has received other investigational therapy in the last 60 days
- The patient has previously been implanted with permanent beacon transponders
- The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials
- The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
21C Oncology - Scottsdale
Scottsdale, Arizona, 85251
Metropolitan Uro-Rad
St Louis, Missouri, 63141
About this study
Official title: The Probe Study - The PROstate Bed Evaluation - A Study to Record the Implant Experience, Transponder Stability and Tracking Data of the Calypso 4D Localization Study in the Prostate Bed
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.
Read the detailed description
Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Observation of transponder stability
- Keywords
- prostate, prostate bed, periprostatic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of transponder stabilityOther
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| stability of Beacons in prostatic bed | Patients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability. Receives: Other: Observation of transponder stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy
Measured: Immediate
Secondary outcomes (1)
Evaluate the stability of the Calypso transponder in the prostate bed
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajanish Singla, MD, Principal investigator, Metro Uro-Rad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763152
- Sponsor's protocol ID
- CMT-07-08
- Status last verified
- Oct 2015
- First submitted
- 25 Sep 2008
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009.
PubMed 15708277Litzenberg DW, Willoughby TR, Balter JM, Sandler HM, Wei J, Kupelian PA, Cunningham AA, Bock A, Aubin M, Roach M 3rd, Shinohara K, Pouliot J. Positional stability of electromagnetic transponders used for prostate localization and continuous, real-time tracking. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1199-206. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21.
PubMed 17513060Kupelian P, Willoughby T, Mahadevan A, Djemil T, Weinstein G, Jani S, Enke C, Solberg T, Flores N, Liu D, Beyer D, Levine L. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. doi: 10.1016/j.ijrobp.2006.10.026. Epub 2006 Dec 21.
PubMed 17187940
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Probe Study - The PROstate Bed Evaluation - A Study to Record the Implant Experience, Transponder Stability and Tracking Data of the Calypso 4D Localization Study in the Prostate Bed
- ClinicalTrials.gov ID
- NCT00763152
- Acronym / sponsor ID
- CMT-07-08
- Conditions
- Prostate Cancer
- Keywords
- prostate, prostate bed, periprostatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stability of Beacons in prostatic bed | – | Other: Observation of transponder stabilityPatients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer of the peri-prostatic tissue or prostate bed
Key inclusion criteria (7 listed)
- Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma
- Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
- Patients being planned for radiation therapy
- Patient is being planned for implant with Calypso Transponders in the prostate bed
- No evidence of distant metastases
Key exclusion criteria (4 listed)
- The patient has received other investigational therapy in the last 60 days
- The patient has previously been implanted with permanent beacon transponders
- The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials
- The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of transponder stabilityObservation of transponder stability and placement in the prostatic bed following radical prostatectomy | Other | stability of Beacons in prostatic bed |
Primary outcome
To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy
Time frame: Immediate
1 secondary outcome
Evaluate the stability of the Calypso transponder in the prostate bed
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Background: PubMed 15708277Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009.
- Background: PubMed 17513060Litzenberg DW, Willoughby TR, Balter JM, Sandler HM, Wei J, Kupelian PA, Cunningham AA, Bock A, Aubin M, Roach M 3rd, Shinohara K, Pouliot J. Positional stability of electromagnetic transponders used for prostate localization and continuous, real-time tracking. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1199-206. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21.
- Background: PubMed 17187940Kupelian P, Willoughby T, Mahadevan A, Djemil T, Weinstein G, Jani S, Enke C, Solberg T, Flores N, Liu D, Beyer D, Levine L. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. doi: 10.1016/j.ijrobp.2006.10.026. Epub 2006 Dec 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajanish Singla, MD principal investigator
Metro Uro-Rad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Varian, a Siemens Healthineers Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00763152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.