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

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)"

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.

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.

Inclusion Criteria:

1. Histological confirmation of adenocarcinoma of the prostate.

2. Age > 18 years.

3. 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

4. PSA > 20 ng/mL.

5. Karnofsky index ≥ 70%

6. Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.

7. 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.

8. Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.

9. Having given informed consent in writing.

Exclusion Criteria:

1. Previous hormone treatment during more than 3 months.
2. Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
3. Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
4. Metabolic disease or uncontrolled systemic disease.
5. Previous history of grade III-IV neuropathy (NCI CTCAE v3).
6. Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
7. Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
8. Inflammatory bowel disease.