Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer

Study Overview
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Brief Summary
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A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.

Detailed Description
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Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis. Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.

Official Title
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Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)

Conditions
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Prostate Cancer Stage III, Prostate Cancer Stage IV

Intervention / Treatment
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* Drug: Docetaxel
* Biological: Hormone and radiation therapy
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of adenocarcinoma of the prostate. Age > 18 years. Localized high-risk prostate cancer, defined as: Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade PSA > 20 ng/mL. Karnofsky index ≥ 70% Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3. Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site. Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site. Having given informed consent in writing. Exclusion Criteria: Previous hormone treatment during more than 3 months. Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness. Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma. Metabolic disease or uncontrolled systemic disease. Previous history of grade III-IV neuropathy (NCI CTCAE v3). Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study. Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study. Inflammatory bowel disease.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel, hormone and radiation therapy<br>Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy. | Drug: Docetaxel<br> <br> * Other names: Taxotere;Biological: Hormone and radiation therapy<br> <br> Radiation: Radiation therapy<br> <br> |
| Active Comparator: Hormone and radiation therapy<br>Radiation therapy and hormone therapy | Biological: Hormone and radiation therapy<br> <br> Radiation: Radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy | Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria). | 5 years of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with biochemical recurrence-free survival | The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA. In the remaining patients, the last available follow-up will be taken as the last control | 5 years | 
| Percentage of patients with progression-free survival | The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA, clinical manifestations or death due to disease. In the remaining patients, the last available follow-up will be taken as the last control | 5 years | 
| Percentage of patients with overall survival. | Defined as the time that elapses, in months, between randomization of the patient in the study and the date of death, regardless of the cause. In the remaining patients, the last available follow-up will be taken as the last control. | 5 years | 
| Clinical response rate | The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria. | 5 years | 
| Biochemical response rate. | Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels. | 5 years | 
| Quality of life of the patients | Change from baseline in the Quality of Life Questionnaire C30 scale (QLQ-C30) to week 9. The QLQ-c30 has five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. They are assigned values between 1 and 4 (1: nothing, 2: a few, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with a score from 1 to 7 (1: terrible, 7: excellent). The obtained scores are summed and standardized and gets a score between 0 and 100 | screening and week 9 | 
| Safety profile of the treatment. | Numbers of events evaluated according to NCI criteria CTCAE v3 | 5 years |