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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00237-32 | Other Identifier | IDRCB Number (ANSM_DEDIM) |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boost by CyberKnife | Experimental |
| |
| Boost by linear accelerator | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First part of treatment : Conformal irradiation | Radiation | 23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in rectal functions |
| Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years |
| Change from baseline in urinary function. |
| Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local control of prostate cancer | Local control is defined as:
| 3 years |
| Global and metastase-free survival |
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Inclusion Criteria:
Prostate adenocarcinoma proved by histology
With at least one of this intermediate-risk criterias:
Prostatic volume ≤ 80 cc
No adenopathy(lymph node < 1.5 cm on scanner or MRI and/or in lymph node dissection)
No metastasis (bone scan)
Age >= 18 ans
No prior pelvic irradiation
No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy > 3 months)
Performance status (ECOG) < 1
No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
Life expectancy >= 10 weeks
Patient affiliated to health insurance
Informed consent signed by the patient
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric LARTIGAU, MD, PhD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49933 | France | |||
| Centre Georges François Leclerc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29190707 | Derived | Pasquier D, Nickers P, Peiffert D, Maingon P, Pommier P, Lacornerie T, Martinage G, Tresch E, Lartigau E. Hypofractionated stereotactic boost in intermediate risk prostate carcinoma: Preliminary results of a multicenter phase II trial (CKNO-PRO). PLoS One. 2017 Nov 30;12(11):e0187794. doi: 10.1371/journal.pone.0187794. eCollection 2017. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| Fiducials placement | Procedure | Placement of intra-prostatic markers for the tracking |
|
| Second part : hypofractionated stereotactic boost | Radiation | 3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy |
|
Time measurement between the inclusion and the date of death/metastatic progression
| 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. | Between radiotherapy and boost, and after treatment : every 3 months |
| Sexual toxicity | According to IIEF5 questionnaire ( International Index of Erectile Function ) | Up to 5 years after treatment |
| Technical criteria : Fiducial placement (yes/no) | During the time of treatment |
| Urinary discomfort | According to IPSS questionnaire ( International Prostate Symptom Score) | Up to 5 years after treatment |
| Technical criteria : Cumulative dosimetry (1 time/ 2 times) | During the time of treatment |
| Technical criteria : boost schedule (yes/no) | During the time of treatment |
| Technical criteria : duration of boost | Time between patient's entry and exit of the radiotherapy treatment room | During the treatment |
| Dijon |
| 21079 |
| France |
| Centre Oscar LAMBRET | Lille | 59020 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Val d'Aurelle-Paul Lamarque | Montpellier | 34298 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54500 | France |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |