Focused Stereotactic Radiation Treatment of Prostatic Adenocarcinoma

Study Overview
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Brief Summary
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Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

Detailed Description
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Focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure. Second objectives : objectives: prostate-specific antigen (PSA) response, MRI response, toxicity (CTCAEv4), quality of life (International Prostate Symptom Score (IPSS) and The International Index of Erectile Function (IIEF5) scores). Method At first: Multiparametric Magnetic resonance imaging (MRI) - 12 biopsies within the whole gland. Placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced. Treatment : CyberKnife radiation treatment delivering 36.25 Gy in 5 fractions, in 10 days. Tracking using the 4 fiducials. Critical organs: Rectal and bladder wall: V35<2cc. Bladder neck and urethra: V35<1cc. Salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (IMRT) treatments can in theory remain valid and safe options.

Official Title
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Robotic and Focused Stereotactic Radiation Treatment of Good Prognosis Prostatic Adenocarcinoma

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Cyberknife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostatic adenocarcinoma of Capra score≤2 invading no more than two adjacent of the 12 prostatic zones. Lesions>3mm. Maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, IPSS score ≤15. Exclusion Criteria: systemic disease, ulcerative hemorrhagic ulcer or Crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (TURP), any recurrent prostatitis within the last 3 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Cyberknife|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay between the initial diagnosis and date of salvage treatment | Delay between the initial diagnosis and date of salvage treatment | through study completion, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA evaluation | PSA dosage | 3, 6, 12, 18, 24, 30, 36 months | 
| Birads score evaluation | Multiparametric prostatic MRI | 12, 24, 36 months | 
| Acute and late toxicity | Acute and late toxicity using the CTCAEv4 | 3, 6, 12, 18, 24, 30, 36 months | 
| IPSS evaluation | IPSS score | 12, 24, 36 months | 
| IIEF5 evaluation | IIEF5 score | 12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, good prognosis, focused treatment, Cyberknife