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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.
Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated IMRT boost radiotherapy | Experimental | 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. |
|
| Conventional Fractionated IMRT boost radiotherapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated IMRT boost radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical Progression Free Survival (bPFS) | Phoenix definition of biochemical failure | 5 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of treatment | for toxicity of treatment RTOG classification is applied | 5 years |
| Quality of Life (QOL) | for Quality of Life (QOL) the EORTC C30 and module PR25 is used. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Milecki, PhD., MD | Greater Poland Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lower-Silesian Oncology Centre | Wroclaw | Lower Silesian Voivodeship | 53-413 | Poland | ||
| Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Conventional Fractionated IMRT boost radiotherapy | Radiation | 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. |
|
| 5years |
| 5 years |
| Olsztyn |
| Warmian-Masurian Voivodeship |
| 10-228 |
| Poland |
| Greater Poland Cancer Centre | Poznan | Wielkopolska | 61-866 | Poland |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |