IG-VMAT for Localized Prostate Cancer

Study Overview
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Brief Summary
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To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.

Official Title
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A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: hypofraction
* Radiation: convention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-79 Histologically confirmed prostate adenocarcinoma Clinical stage T1-3N0M0 according to the AJCC 6th edition Gleason score must be >5 KPS >70 No radical surgery or cryosurgery for prostate cancer Exclusion Criteria: Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible) Evidence of distant metastases Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous or concurrent cytotoxic chemotherapy for prostate cancer

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 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: hypofraction<br>70 Gy in 28 fractions over 5.6 weeks | Radiation: hypofraction<br>* 70 Gy in 28 fractions over 5.6 weeks<br>|
| Active Comparator: convention<br>80Gy in 40 fractions over 8 weeks | Radiation: convention<br>* 80Gy in 40 fractions over 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical progression free survival | Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0 |  | From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT | 
| Time to late grade 2+ adverse events as assessed by NCI CTCAE v. 4.0 |  | From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT | 
| Overall Survival |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, radiotherapy