hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Placement of intra-prostatic markers for the tracking
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
Centre Paul Papin
Angers, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar LAMBRET
Lille, France
Centre Léon Bérard
Lyon, France
Change from baseline in rectal functions
* Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Time frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Change from baseline in urinary function.
* Assessment of urinary toxicity according to the NCI-CTCAE v4.0 scale. * Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Time frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years
Local control of prostate cancer
Local control is defined as: * Non progressive PSA according to Phoenix criteria * Non progressive clinical examination (DRE) * No pathological findings on MRI
Time frame: 3 years
Global and metastase-free survival
Time measurement between the inclusion and the date of death/metastatic progression
Time frame: Up to 5 years after treatment
PSA kinetics
Comparison of the PSA dosage before, at the end of treatment then every 3 months. The PSA dosage evolution will be correlate with the local control treatment.
Time frame: Between radiotherapy and boost, and after treatment : every 3 months
Sexual toxicity
According to IIEF5 questionnaire ( International Index of Erectile Function )
Time frame: Up to 5 years after treatment
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Val d'Aurelle-Paul Lamarque
Montpellier, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Technical criteria : Fiducial placement (yes/no)
Time frame: During the time of treatment
Urinary discomfort
According to IPSS questionnaire ( International Prostate Symptom Score)
Time frame: Up to 5 years after treatment
Technical criteria : Cumulative dosimetry (1 time/ 2 times)
Time frame: During the time of treatment
Technical criteria : boost schedule (yes/no)
Time frame: During the time of treatment
Technical criteria : duration of boost
Time between patient's entry and exit of the radiotherapy treatment room
Time frame: During the treatment