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Search / Trial NCT01589939

Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System

Launched by U.S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY · May 1, 2012

Trial Information

Current as of May 17, 2025

Unknown status

Keywords

Reduced Planning Target Volume Radiation Therapy Calypso

ClinConnect Summary

This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:

* decreased acute and chronic adverse effects with similar local tumor control
* dose escalation to achieve higher cure rates with similar adver...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Histologically confirmed adenocarcinoma of the prostate
  • Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
  • Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
  • Ability to comply with study schedule
  • Age 40 or older
  • Zubrod PS 0 or 1
  • Signed informed consent
  • Exclusion Criteria:
  • Node positive or metastatic prostate cancer
  • Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
  • History of prior pelvic radiotherapy
  • History of abdominoperineal resection
  • History of HIV infection
  • History of chronic prostatitis or chronic cystitis
  • History of bleeding disorder or any active anticoagulation (excluding ASA)
  • PT or INR outside normal range for institution
  • Active implanted devices such as cardiac pacemakers and automatic defibrillators.
  • Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
  • Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 8).
  • Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.

About U.S. Army Medical Research Acquisition Activity

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is a vital component of the Department of Defense, dedicated to advancing military medicine through the acquisition and management of innovative research and development projects. USAMRAA facilitates the procurement of medical solutions that enhance the health and performance of military personnel, while also contributing to broader public health objectives. By fostering collaboration with various stakeholders, including academic institutions, industry partners, and governmental agencies, USAMRAA plays a crucial role in ensuring the timely delivery of cutting-edge medical technologies and treatments that address the unique challenges faced by service members and their families.

Locations

Tacoma, Washington, United States

Patients applied

0 patients applied

Trial Officials

Dusten Macdonald, MD

Principal Investigator

Department of the Army

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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