3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy
* Other: Arm A: 3D-Conformal Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A pathologic diagnosis of adenocarcinoma of the prostate Age greater than 18 years ECOG performance status of 2 or less. Presence of any of the following high risk features: Clinical stage cT3-4 or Gleason score 8-10 or Pre-treatment PSA &gt; 20ng/ml or Clinical N1/N2 or pathologic N1/N2 Exclusion Criteria: Patients with contraindication to radical radiation therapy including inflammatory bowel disease Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer Prior pelvic radiotherapy for other malignancies Prior cytotoxic chemotherapy Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A: 3D-Conformal Radiation<br>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<br>* 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<br>* Other names: Radiation Therapy;|
| Experimental: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy<br>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<br>* 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<br>* Other names: IMRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late rectal toxicity from radiotherapy of the prostate | Outcome measurements will be determined by physical exam and bloodwork. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Outcome measurements will be determined by physical exam and bloodwork. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, IMRT, tomotherapy, radiation, cancer