Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.
Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Stereotactic SBRT | Experimental | By assuming a hypofractionated irradiation scheme, it is assumed that between the fractions sublethal radiation damage is being treated and the time factor does not significantly affect RT result. The SBRT fractional dose was determined on the basis of a Biologically Effective Dose (BED) calculation using a linear-square model, which assumes that α / β takes the following values for:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival time without biochemical recurrence, | Phoenix definition of biochemical failure | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| survival time specific for prostate cancer, | the period of time from randomization until death from prostate cancer | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| QoL-EORTC quality of life | For QoL the EORTC questionnaire (C30 with PR25) is used. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Milecki, PhD., MD | Contact | +48618850878 | piotr.milecki@wco.pl | |
| Sylwia KrÄ…kowska, MD | Contact | +48 61 885 08 78 | sylwia.krakowska@wco.pl |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Milecki, PhD., MD | Greater Poland Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Poland Cancer Centre | Recruiting | Poznan | Wielkopolska | 61-866 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |