Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

Study Overview
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Brief Summary
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There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.

Official Title
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Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of prostate cancer With age between 18-75 years classified in low Intermediate and high-risk group according to their Gleason score T stage and initial PSA (iPSA). Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL. Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL. All patients classified as high risk was submitted to the bone scans. Exclusion Criteria: Patients with metastases Prior history of prostatectomy Pelvic radiotherapy treatment Chemotherapy treatment were excluded of this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: IMRT- Hypofractionated schedule 70 Gy/25 fx<br>The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator. | Radiation: IMRT<br>* The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV. The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.<br>* Other names: 3DCRT;|
| Active Comparator: 3DCRT-Hypofractionated schedule 70 Gy/25 fx<br>The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator. | Radiation: IMRT<br>* The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV. The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.<br>* Other names: 3DCRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal and geniturinary acute toxicity | The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder. | 6 months | 
| Gastrointestinal and geniturinary late toxicity | Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical control | The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionated schedule, Intensity Modulated Radiotherapy, Conformal radiotherapy