NCT00129025

Brief Summary

Many patients with localized prostate cancer choose radiotherapy for treatment. Recent improvements in technology have lead to better outcomes with less side effects and better disease control rates by allowing high doses of radiation to be delivered to the cancer with lower doses to surrounding healthy tissues. Currently patients are required to attend daily treatments over seven to eight weeks which can be costly and disruptive for patients, especially those not living close to a cancer centre. There is recent research that suggests that the same or better outcomes might be achieved in prostate cancer by delivering a smaller number of treatments, but with a higher dose of radiation given on each visit, over a shorter time than the usual seven to eight weeks. In this study the investigators propose to treat patients with prostate cancer using 16 treatments over four weeks, thus reducing the number of visits to the cancer centre for treatment by 50%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 10, 2011

Status Verified

October 1, 2011

Enrollment Period

2.2 years

First QC Date

August 9, 2005

Last Update Submit

October 6, 2011

Conditions

Prostate Cancer

Keywords

conformal hypofractionated radiotherapylocalized prostate cancer

Outcome Measures

Primary Outcomes (1)

  • rectal toxicity

    Study completion

Secondary Outcomes (1)

  • Prostate-specific antigen (PSA) control

    Study completion

Interventions

Hypofractionated radiotherapyPROCEDURE

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Low/intermediate risk localized prostate cancer

You may not qualify if:

  • High risk, metastatic
  • Patient refusal

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 Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Robert Pearcey, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 10, 2011

Record last verified: 2011-10

Locations

CA(1)