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Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Late rectal toxicity from radiotherapy of the prostate

Principal Investigator

Shawn Malone, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ottawa Hospital Research Institute


Canada: Health Canada

Study ID:




Start Date:

November 2005

Completion Date:

May 2014

Related Keywords:

  • Prostate Cancer
  • prostate, IMRT, tomotherapy, radiation, cancer
  • Prostatic Neoplasms