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.
Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows: 1. Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival. 2. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors. 3. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors. 4. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors. 5. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
288
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.
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.
Lower-Silesian Oncology Centre
Wroclaw, Lower Silesian Voivodeship, Poland
Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
Olsztyn, Warmian-Masurian Voivodeship, Poland
Greater Poland Cancer Centre
Poznan, Wielkopolska, Poland
biochemical Progression Free Survival (bPFS)
Phoenix definition of biochemical failure
Time frame: 5 years
Cause Specific Survival (CSS)
the period of time from randomization until death from prostate cancer
Time frame: 5 years
Overall Survival (OS)
the period of time from randomization until death from any causes
Time frame: 5years
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