CMT-07-08: The PROstate Bed Evaluation Study

NCT ID: NCT00763152

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

Brief Summary

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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

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Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observation of transponder stability

Intervention Type OTHER

Observation of transponder stability and placement in the prostatic bed following radical prostatectomy

Interventions

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Observation of transponder stability

Observation of transponder stability and placement in the prostatic bed following radical prostatectomy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Varian, a Siemens Healthineers Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajanish Singla, MD

Role: PRINCIPAL_INVESTIGATOR

Metro Uro-Rad

Locations

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21C Oncology - Scottsdale

Scottsdale, Arizona, United States

Site Status

Metropolitan Uro-Rad

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15708277 (View on PubMed)

Litzenberg 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.

Reference Type BACKGROUND
PMID: 17513060 (View on PubMed)

Kupelian 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.

Reference Type BACKGROUND
PMID: 17187940 (View on PubMed)

Other Identifiers

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CMT-07-08

Identifier Type: -

Identifier Source: org_study_id

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