NCT00122265

Brief Summary

Prostate cancer is the most common malignancy in males, and radiotherapy is a commonly chosen treatment option for patients with localized disease. Technical innovations such as three-dimensional conformal radiotherapy (3D CRT) and intensity-modulated radiotherapy permit radiation dose escalation and possibly better disease outcomes, but escalated doses may be accompanied by long-term complications. This study will examine, for the first time, the independent contribution of a patient's own genetic makeup to the development of post-radiation complications, permitting the future development of predictive tests to avoid radiation injury. To do this, the investigators will examine gene markers and blood proteins in a series of approximately 100 prostate cancer survivors who have received three-dimensional conformal radiotherapy between 1996 and 2000 at the Cross Cancer Institute.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 26, 2016

Status Verified

April 1, 2012

Enrollment Period

8.8 years

First QC Date

July 20, 2005

Last Update Submit

February 24, 2016

Conditions

Prostate Cancer

Keywords

prostate cancerradiotherapyradiation toxicitysingle nucleotide polymorphism

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Treatment with 3D CRT for which follow-up toxicity evaluation was done

You may not qualify if:

  • Follow-up less than 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesWounds and Injuries

Study Officials

  • Matthew Parliament, MD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

April 1, 2003

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 26, 2016

Record last verified: 2012-04

Locations

CA(1)