Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

Study Overview
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Brief Summary
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As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance

Detailed Description
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Primary endpoint: PSA progression rate, ASTRO guidelines. Secondary endpoints: PSA doubling time after progression Quality of Life (QoL) Safety Metastases free survival Overall survival

Official Title
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Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-risk Prostate Cancer Treated With Radical Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men > 18 and ≤75 years of age. WHO/ECOG performance status 0 - 1. Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation One of the following: T2 with Gleason score 7(4+3 ) and PSA >10 ng/ml to < 70 ng/ml T2 with Gleason 8-10, any PSA < 70 ng/ml any T3 tumour Prior neoadjuvant hormone therapy is mandatory for all patients Adequate haematological-, liver- and kidney function. (Hemoglobin > 110 g/l, neutrophils > 1.5 x 109/ l, platelets > 150 x 109/ l, ASAT and ALAT < 1.5 x ULN, ALP < 1.5 x ULN, creatinine < 1.5 x ULN) Written informed consent Exclusion Criteria: M+ N+ clinical or pathological Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years. Previous radiotherapy to the pelvic region. Previous chemotherapy within 5 years. Systemic corticosteroids within 6 months prior to randomisation. Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation. Active untreated infectious disease, including tuberculosis, MRSA. Active gastric ulcer. Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel) Other serious illness or medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel arm<br>six of docetaxel every third week + hormonal treatment | Drug: docetaxel<br>* docetaxel 75 mg/square meter i.v. every third week, six cycles<br>* Other names: LHRH ananlog 9 months;|
| No Intervention: Control<br>hormonal treatment only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA progression rate | According to RTOG-ASTRO guidelines | From randomization to progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA doubling time after progression, quality of life, safety, metastases free survival, overall survival | PSA doubling measured, FACT-P, detection of metastatic lesions | From randomisation to year 2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvant treatment, high risk, radical radiotherapy