Intensity Modulated Radiation Therapy - Prostate Cancer

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

First Received: September 12, 2005 Last Updated: December 28, 2005 History of Changes

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188513

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 I Phase II

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate

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

Secondary Outcome Measures:

To evaluate acute toxicity of therapy
To evaluate local control as assessed by prostate biopsy at 2.5 years
To evaluate time to disease progression

Estimated Enrollment:	267
Study Start Date:	May 2001

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

Contacts

Contact: Charles Catton, MD

416-946-2121

charles.catton@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Charles Catton, MD 416-946-2121 charles.catton@rmp.uhn.on.ca

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

Study ID Numbers:	UHN REB 01-0181-C
Study First Received:	September 12, 2005
Last Updated:	December 28, 2005
ClinicalTrials.gov Identifier:	NCT00188513 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009