NCT02300389

Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: The Greater Poland Cancer Centre · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated IMRT boost radiotherapy	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	Conventional Fractionated IMRT boost radiotherapy	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-11-25
• Last updated: 2020-02-06

Locations

3 sites across 1 country: Poland