CMT-07-08: The PROstate Bed Evaluation Study

NCT00763152 | Completed

• 1 other identifier: CMT-07-08
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate; prostate bed; periprostatic

Outcome Measures

Primary Outcomes (1)

• To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy

  Immediate

Secondary Outcomes (1)

• Evaluate the stability of the Calypso transponder in the prostate bed

  60 days

Study Arms (1)

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.

Other: Observation of transponder stability

Interventions

Observation of transponder stability OTHER

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

stability of Beacons in prostatic bed

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer of the peri-prostatic tissue or prostate bed

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (2)

21C Oncology - Scottsdale

Scottsdale, Arizona, 85251, United States

Location

Metropolitan Uro-Rad

St Louis, Missouri, 63141, United States

Location

Related Publications (3)

• 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.

  PMID: 15708277 BACKGROUND

• 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.

  PMID: 17513060 BACKGROUND

• 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.

  PMID: 17187940 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rajanish Singla, MD

  Metro Uro-Rad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

US (2)