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

NCT01589939 | Unknown DMC

• 2 other identifiers: W81XWH-08-2-0174, A-15214.1a207111
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.

Conditions

Prostate Cancer

Keywords

Reduced Planning Target Volume; radiation therapy; Calypso

Outcome Measures

Primary Outcomes (1)

• Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use

  During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.

  Approximately 8.5 weeks (43 fractions per pt.)

Secondary Outcomes (2)

• Analyze dosimetric characteristics of treatment planning

  usually within the first 2 weeks after beacon placement (done at simulation CT)

• Assess incidence of acute bladder and rectal toxicity

  approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research Acquisition Activity: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Madigan Healthcare System

Tacoma, Washington, 98431, United States

Location

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

• Dusten Macdonald, MD

  Department of the Army

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MC

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 2, 2012
• Study Start: March 1, 2009
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)