Clinical trial · Interventional
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
NCT02300389CI-TRIAL-00043236HYPOPROSTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Fractionated IMRT boost radiotherapy | Radiation | — | UNRESOLVED |
| Hypofractionated IMRT boost radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated IMRT boost radiotherapy
- description
- 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.
- interventionNames
- Radiation: Hypofractionated IMRT boost radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionated IMRT boost radiotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.