Clinical trial NCT02300389: Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated
Official title: Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: high risk prostate cancer radiotherapy hypofractionation
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 288
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: biochemical Progression Free Survival (bPFS)
timeFrame: 5 years
Secondary outcomes:
measure: Cause Specific Survival (CSS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5years
Other outcomes:
measure: Toxicity of treatment
timeFrame: 5 years
measure: Quality of Life (QOL)
timeFrame: 5 years
Locations:
city: Wroclaw
country: Poland
facility: Lower-Silesian Oncology Centre
state: Lower-Silesian
city: Olsztyn
country: Poland
facility: Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
state: Warmia-mazury
city: Poznan
country: Poland
facility: Greater Poland Cancer Centre
state: Wielkopolska
Study officials:
affiliation: Greater Poland Cancer Centre
name: Piotr Milecki, PhD., MD
role: PRINCIPAL_INVESTIGATOR
References: