Status:
COMPLETED
Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated
Lead Sponsor:
The Greater Poland Cancer Centre
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
NA
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 Andro...
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/predict...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT02300389
Start Date
December 1 2011
End Date
December 1 2019
Last Update
February 6 2020
Active Locations (3)
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1
Lower-Silesian Oncology Centre
Wroclaw, Lower Silesian Voivodeship, Poland, 53-413
2
Independent Public Healthcare of Ministry of Interior with Warmia and Mazury Oncology Centre
Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
3
Greater Poland Cancer Centre
Poznan, Wielkopolska, Poland, 61-866