Intensity Modulated Radiation Therapy - Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188513
First received: September 12, 2005
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.


Condition Intervention Phase
Prostatic Neoplasms
Procedure: conformal intensity modulated radiotherapy (IMRT)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca [ Time Frame: at each post treatment follow-up for up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate acute toxicity of therapy [ Time Frame: weekly during RT ] [ Designated as safety issue: Yes ]
  • To evaluate local control as assessed by prostate biopsy at 2.5 years [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To evaluate time to disease progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 267
Study Start Date: May 2001
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conformal intensity modulated radiotherapy (IMRT)
All patients shall receive a continuous course of intensity modulated conformal radiotherapy consisting of 66 Gy in 22 (3 Gy) fractions over 4.5 weeks.
Procedure: conformal intensity modulated radiotherapy (IMRT)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
  • Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
  • Patients with a PSA >10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of >8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score >8, or any patient with a Gleason score of 7, and a PSA >10.
  • The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
  • ECOG performance status of 1 or less
  • Age 80 years old or less
  • Serum PSA <25 ng/ml within 4 weeks of study entry
  • Informed consent

Exclusion Criteria:

  • Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
  • Patients with prior colorectal surgery
  • Any prior pelvic radiotherapy. Any prior TURP done <12 weeks from study entry.
  • Any previous cytotoxic chemotherapy
  • Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188513

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Charles Catton, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188513     History of Changes
Other Study ID Numbers: UHN REB 01-0181-C
Study First Received: September 12, 2005
Last Updated: May 28, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 21, 2014