NCT00326638

Brief Summary

In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).

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
72

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable prostate-cancer

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, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

9.8 years

First QC Date

May 15, 2006

Last Update Submit

April 15, 2020

Conditions

Prostate Cancer

Keywords

prostate, IMRT, tomotherapy, radiation, cancer

Outcome Measures

Primary Outcomes (1)

  • Late rectal toxicity from radiotherapy of the prostate

    Outcome measurements will be determined by physical exam and bloodwork.

    Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression

Secondary Outcomes (1)

  • Acute rectal toxicity, Acute and late bladder toxicity, Disease specific survival at 5 years, Biochemical relapse free survival at 5 years, Local control rates at 5 years, Quality of Life

    Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression

Study Arms (2)

Arm A: 3D-Conformal Radiation

OTHER

Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks. 3DCRT 7800 cGY/39 Fractions/ STD Technique\* * Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23 * Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Other: Arm A: 3D-Conformal Radiation

Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

EXPERIMENTAL

Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks. IMRT using Helical Tomotherapy\* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16

Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

Interventions

Arm B: Helical Tomotherapy Intensity Modulated RadiotherapyRADIATION

IMRT using Helical Tomotherapy\* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks * Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23 * Boost IMRT to Prostate 3,200 cGy/16

Also known as: IMRT
Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
Arm A: 3D-Conformal RadiationOTHER

3DCRT 7800 cGY/39 Fractions/ STD Technique\* once daily Monday to Friday for 8 weeks * Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23 * Boost 6 F 3DCRT to Prostate 3,200 cGy/16

Also known as: Radiation Therapy
Arm A: 3D-Conformal Radiation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A pathologic diagnosis of adenocarcinoma of the prostate
  • Age greater than 18 years
  • ECOG performance status of 2 or less.
  • Presence of any of the following high risk features:
  • Clinical stage cT3-4 or
  • Gleason score 8-10 or
  • Pre-treatment PSA \> 20ng/ml or
  • Clinical N1/N2 or pathologic N1/N2

You may not qualify if:

  • Patients with contraindication to radical radiation therapy including inflammatory bowel disease
  • Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
  • Prior pelvic radiotherapy for other malignancies
  • Prior cytotoxic chemotherapy
  • Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shawn Malone, MD

    Ottawa Hospital Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

March 1, 2005

Primary Completion

January 1, 2015

Study Completion

June 30, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

CA(1)