Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

Study Overview
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Brief Summary
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The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients combined with Androgen Deprivation Therapy.

Detailed Description
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Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows: Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).

Official Title
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Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated IMRT boost radiotherapy
* Radiation: Conventional Fractionated IMRT boost radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men from 40 to 75 years old with confirmed prostate adenocarcinoma, prostate biopsy will be performed <180 days before the date of randomization, completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; Gleason score ≤ 7 versus Gleason score> 8, general condition according to the classification of the Eastern Cooperative Oncology Group (ECOG) 0 - 1), (Appendix 1), Androgen Deprivation Therapy: prior Radiotherapy (RT) (minimum 3 months before the start of RT), concurrently with RT and after RT during follow-up (24 months) , high risk of Prostate Cancer progression defined as presence of at least one of the following factors: cT3, Gleason> 7, PSA> 20 ng / ml or presence of at least two of cT2c, Gleason 7, PSA in the range of 10.1 ng / ml to 19.9 ng / ml, cT defined by AJCC staging 7 edition, (Appendix 2), PSA identified at least 10 days after the biopsy or before, and patients receiving fiansteryd 30 days after the cessation of therapy, no regional and distant metastases confirmed by bone scintigraphy, chest radiograph, computed tomography/magnetic resonance imaging of the pelvis, signing an informed consent to participate in a medical experiment (radiotherapy + biological material samples) (Annex 3), morphological and biochemical parameters within normal limits. Exclusion Criteria: the presence of active cancer except skin cancer preceding period of 5 years prior to randomization, Early surgery (radical prostatectomy) or pelvic RT, earlier hormonal therapy than is advocated in this study, co-morbidities that may significantly affect the expectancy life of the patients do not meet the criteria for inclusion.

Ages Eligible for Study
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Minimum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated IMRT boost radiotherapy<br>All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with hypofractionated dose of 7.5 Gy in two fractions (II phase) to the total dose of 61 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months. | Radiation: Hypofractionated IMRT boost radiotherapy<br>* All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with hypofractionated dose of 7.5 Gy in two fractions (II phase) to the total dose of 61 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.<br>|
| Active Comparator: Conventional Fractionated IMRT boost radiotherapy<br>All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with conventional fractionated dose of 2 Gy in 15 fractions (II phase) to the total dose of 76 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months. | Radiation: Conventional Fractionated IMRT boost radiotherapy<br>* All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with conventional fractionated dose of 2 Gy in 15 fractions (II phase) to the total dose of 76 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical Progression Free Survival (bPFS) | Phoenix definition of biochemical failure | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause Specific Survival (CSS) | the period of time from randomization until death from prostate cancer | 5 years | 
| Overall Survival (OS) | the period of time from randomization until death from any causes | 5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk prostate cancer radiotherapy hypofractionation