NCT01624623

Brief Summary

This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer. Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

6.2 years

First QC Date

June 18, 2012

Last Update Submit

September 9, 2015

Conditions

Prostate Cancer

Keywords

radiationCalypsoprostatectomy

Outcome Measures

Primary Outcomes (2)

  • Interfraction prostate bed motion

    For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion. 1. Inferior (defined as 8 mm below VUA) 2. Superior (top of seminal vesicle remnant or superior most CTV slice) 3. Middle (defined as the slice equally distant from the inferior and superior slices above)

    Approximately 7.5 weeks (36-39 fractions per pt.)

  • Intrafraction prostate bed motion

    Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.

    Approximately 7.5 weeks (36-39 fractions per pt.)

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include high risk patients referred for adjuvant or salvage radiation therapy after radical prostatectomy based upon the presence of unfavorable characteristics after prostatectomy, which include positive surgical margins, extracapsular extension of disease, or immediately detectable PSA.

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic extension.
  • Ability to comply with study schedule
  • Age 40 or older
  • Zubrod PS 0 or 1 (appendix 1)
  • Signed informed consent

You may not qualify if:

  • Node positive or metastatic prostate cancer
  • History of prior pelvic radiotherapy
  • History of abdominoperineal resection
  • History of inflammatory bowel disease or connective tissue disease
  • History of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder placement.
  • 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 5).
  • History of HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madigan Healthcare System

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale 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

June 18, 2012

First Posted

June 20, 2012

Study Start

March 1, 2010

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

US(1)