Shorter Radiation Schedule for the Treatment of Prostate Cancer

Study Overview
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Brief Summary
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To improve the management of patients with early stage prostate cancer.

Detailed Description
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To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.

Official Title
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A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: 5250 cGy/20 fractions over 28 days
* Procedure: 6600 cGy/33 fractions over 45 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification Exclusion Criteria: PSA > 40 mcg/L previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured simulated volume exceeds 1000 cm3 previous pelvic radiotherapy inflammatory bowel disease serious non-malignant disease which would preclude radiotherapy or surgical biopsy geographic inaccessibility for follow-up psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy failure to give informed consent to participate in the study
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>5250 cGy in 20 fractions over 28 days | Procedure: 5250 cGy/20 fractions over 28 days<br>* see above<br>* Other names: short fractionation schedule;|
| Active Comparator: 2<br>6600 cGy in 33 fractions over 45 days | Procedure: 6600 cGy/33 fractions over 45 days<br>* see above<br>* Other names: standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to PSA failure |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive biopsy at two years post radiation |  | see above | 
| disease free survival |  | 10 years | 
| toxicity |  | 10 years | 
| quality of life |  | 6 years | 
| economic |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostate specific antigen, PSA, radiation fractionation