Trial record 1 of 1 for:    NCT00326638
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3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00326638
First received: May 15, 2006
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
Other: Arm A: 3D-Conformal Radiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Late rectal toxicity from radiotherapy of the prostate [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Outcome measurements will be determined by physical exam and bloodwork.


Secondary Outcome Measures:
  • 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Outcome measurements will be determined by physical exam and bloodwork.


Estimated Enrollment: 72
Study Start Date: November 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A: 3D-Conformal Radiation

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

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
Other Name: Radiation Therapy
Experimental: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

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

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
Other Name: IMRT

Detailed Description:

Radical radiation therapy plays an important role in the management of prostate cancer, yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free survival data using PSA criteria have shown that less than 50% of high-risk patients are free of disease at 10 years. To improve on the results of conventional dose radiotherapy dose escalation with three-dimensional conformal radiation has been employed. Due to the irregular shape of the prostate and the variable motion of this organ there is substantial radiation of adjacent normal surrounding tissue during treatment which results in radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution during radiation therapy of the prostate. The hypothesis of this study is that IMRT delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A pathologic diagnosis of adenocarcinoma of the prostate
  2. Age greater than 18 years
  3. ECOG performance status of 2 or less.
  4. 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

Exclusion Criteria:

  1. Patients with contraindication to radical radiation therapy including inflammatory bowel disease
  2. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
  3. Prior pelvic radiotherapy for other malignancies
  4. Prior cytotoxic chemotherapy
  5. Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326638

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Grimes    613-737-7700 ext 70523    sgrimes@ohri.ca   
Contact: Lorraine Millar    613-737-7700 ext 70306    lmillar@ohri.ca   
Principal Investigator: Shawn Malone, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Study Director: Shawn Malone, MD Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00326638     History of Changes
Other Study ID Numbers: 2005242-01H, OTT 05-02
Study First Received: May 15, 2006
Last Updated: February 17, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
prostate, IMRT, tomotherapy, radiation, cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014