A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate
Prostate cancer is now the most commonly diagnosed cancer in Canadian men and is the third
most common cause of cancer death.1 Locally advanced prostate cancer (clinical T3/T4) is
uncommon in North America because of earlier diagnosis following widespread PSA testing and
patient information campaigns. However, in the past decade the term high-risk prostate
cancer has been developed to include the previous locally advanced disease and patient with
T1/T2 disease with poor prognostic features (either a high Prostate Specific Antigen or high
Gleason score). The risk of involvement of pelvic lymph nodes by prostate cancer for certain
subgroups of intermediate risk and most high risk prostate cancer may be substantial. The
long term results of conventional dose (66-70 Gy) external beam radiation therapy for
intermediate and locally advanced prostate cancer have been disappointing. The combination
of hormonal therapy and radiation therapy or radiation therapy dose escalation are the two
strategies which have been evaluated and are now used to improve these results.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.
after all patients have completed study intervention
Yes
Andrew Bayley, MD
Principal Investigator
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
UHN REB 05-0396-C
NCT00915122
November 2005
November 2014
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