Hypofractionated Stereotactic Boost in Prostate Cancer

Study Overview
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Brief Summary
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hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Detailed Description
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The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Official Title
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Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

Conditions
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Cancer

Intervention / Treatment
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* Radiation: First part of treatment : Conformal irradiation
* Procedure: Fiducials placement
* Radiation: Second part : hypofractionated stereotactic boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate adenocarcinoma proved by histology With at least one of this intermediate-risk criterias: T2b and/or PSA between 10 et 20 ng/ml and/or Gleason score = 7 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: Cancer no histologically proved Unfavorable-risk(T2c and/or PSA > 20 ng/ml and/or Gleason > 7) Favorable-risk(T1c T2a and PSA < 10 ng/ml and Gleason < 7) T3 and T4 History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin) Contraindication to MRI IPSS score > 10 Recurrent or metastatic disease Allergy to gold Patient already included in another therapeutic trial with an experimental molecule Unable for medical follow-up (geographic, social or mental reasons)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boost by CyberKnife<br> | Radiation: First part of treatment : Conformal irradiation<br>* 23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy<br>Procedure: Fiducials placement<br>* Placement of intra-prostatic markers for the tracking<br>Radiation: Second part : hypofractionated stereotactic boost<br>* 3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy<br>|
| Experimental: Boost by linear accelerator<br> | Radiation: First part of treatment : Conformal irradiation<br>* 23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy<br>Procedure: Fiducials placement<br>* Placement of intra-prostatic markers for the tracking<br>Radiation: Second part : hypofractionated stereotactic boost<br>* 3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 
| Global and metastase-free survival | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer