FAQs—Calypso

What is the Calypso® 4D Localization System?

Known GPS for the Body®, Calypso’s proprietary technology uses tiny electromagnetic transponders placed in the prostate or, after the prostate has been removed, in the prostate bed to provide precise, continuous information on the location of the tumor during external beam radiation therapy. The Calypso® 4D Localization System is the only technology platform designed to provide objective, accurate and continuous tracking information during external beam radiation therapy without adding ionizing radiation.

Why is organ motion a concern in prostate and prostate bed radiation treatment?

Prior to radiation treatment, the patient is positioned such that the radiation is directed at the tumor and away from normal, healthy tissue. Organ motion, which naturally occurs as a result of normal body physiology, may cause the prostate or prostate bed to move, potentially compromising the precise delivery of radiation during treatment. Detecting the slightest tumor movement in real-time allows for the delivery of extremely accurate radiation while assisting doctors in their efforts to minimize damage to healthy surrounding organs and tissues, which can lead to common side effects such as impotence, incontinence and loss of bowel function.

How does the Calypso System work?

The Calypso 4D Localization System utilizes three Beacon® electromagnetic transponders, each smaller than a grain of rice, which are permanently implanted in the prostate or prostate bed during a simple outpatient procedure prior to external beam radiation therapy. The Beacon transponders – comprised of wireless electromagnetic circuits – are designed to interact with the Calypso System, allowing the clinician guidance to precisely position the patient prior to radiation therapy treatment and continuously monitor the tumor’s position during each treatment session.

Additionally, Calypso Medical offers an Adaptive Couch RepositioningTM feature, providing connectivity with Varian Medical Systems’ 4D integrated treatment console (4DITC) to allow the therapist to realign the treatment couch in a matter of seconds, from outside the treatment room, when the Calypso System detects significant organ motion.

Can this treatment be used for patients who have had a prostatectomy, have had a recurrence or are at high-risk for recurrence?

Yes. Radiation therapy is the standard of care for patients whose cancer has recurred or are at a high-risk of recurrence. In May 2008, Calypso Medical received clearance from the FDA for post-prostatectomy patients at risk of, or diagnosed with, recurrent prostate cancer. Studies indicate more than 20% of prostatectomy patients are diagnosed with recurrent prostate cancer and require adjuvant radiation therapy.

Is there clinical data that supports the efficacy of “GPS for the Body?”

Data on the Calypso 4D Localization System and Beacon transponders have been featured in more than 15 published peer-reviewed articles and the topic of more than 100 abstracts at major medical meetings. Notably, results from a clinical study published in the March 2007 issue of the International Journal of Radiation Oncology Biology Physics1 demonstrated the Calypso 4D Localization System is a clinically efficient and objective localization method for positioning prostate patients undergoing radiation therapy. The study found initial treatment setup can be performed rapidly, accurately and objectively before radiation delivery. The extent and frequency of prostate motion during radiation therapy can be easily monitored and used for adaptive motion management.

The study is the only continuous, real-time, and objective setup and tracking study of the prostate during external beam radiation therapy, with more than 2,000 fractions recorded. 97% of patients exceeded preset thresholds at some point during their radiation therapy.

How many medical centers offer “GPS for the Body?”

More than six dozen leading cancer centers across the nation are utilizing the Calypso System, including Fox Chase Cancer Center in Philadelphia, MD Anderson Cancer Center in Orlando, the University of Pennsylvania, the Swedish Medical Institute in Seattle, Washington University Medical Center, the Seattle Cancer Care Alliance, and the University of Michigan.

Can “GPS for the Body” be used in conjunction with other treatments?

Calypso Medical is currently working with The University of Pennsylvania Health System to develop a compatible version of the Calypso 4D Localization System that would enable real-time tumor tracking during proton therapy for cancer treatment. Calypso Medical expects this targeting platform to provide benefits body-wide with applications identified for prostate, breast, lung, cervical and abdominal cancers.