CyberKnife for Prostate Cancer Patients Aged 70 y or More

Study Overview
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Brief Summary
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Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly. Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml. Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores>5. Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.

Detailed Description
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Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly. Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes. Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation. Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml. Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores>5. Doses to the Organs At Risk (OAR) : Rectum wall : V36.25<2%, V27<20%, V23<30%, V20<35%. Bladder wall : V36.25<2%, V27<20%, V20<35%. Considering specifically the prescription of 37.5 Gray, the rectum and bladder wall: V37.5<2%. Anytime, hot spots of 105 % of the prescription dose must avoid the urethra. Evaluation criteria : CTCAEV4 (Common Toxicity Criteria for Adverse Events, version4), PSA, multiparametric MRI, IPSS (International Prostate Score Symptom) and IIEF5 (International Index of Erectile Function). Methodolgy : this is a three step prospective, observational study of 20 patients each step. Before moving to the next step, the severe acute or late toxicity at a median follow-up of 1 year must remain below 5% each.

Official Title
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Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml, WHO (World Health Organisation) score<2, IPSS≤15, maximal urinary flow rate ≥15ml/s, mean urinary flow rate ≥5ml/s, multiparametric prostatic and pelvis MRI Exclusion Criteria: Prostatic volume > 100cc, TURP (transurethral prostatectomy) <3 y, any recurrent prostatitis within the last 3 years, collagenose diseases, ulcero-haemorrhagic rectocolitis or crohn diseases

Ages Eligible for Study
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Minimum Age: 70 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late toxicity (Using the CTCAEv4) | Using the CTCAEv4 | During 36 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA evaluation | PSA Dosage | at 4 and 6 months, than every 6 months for 3 years | 
| Digital rectal exam | Clinical examination (digital rectal exam) | at 6, 12, 24 and 36 months | 
| Birads score evaluation | Multiparametric prostatic MRI | at 36 months | 
| IPSS evaluation | IPSS score | at 12, 24 and 36 months | 
| IIEF5 evaluation | IIEF5 score | at 12, 24 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, cancer, radiation, stereotactic, CyberKnife, elderly