Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer

Exclusion Criteria

• •1. Any treatment with investigational drugs, chemotherapy or immunotherapy within 30 days prior to receiving the first dose of investigational treatment; Patients may be on ADT as long as this is has not been longer than 4 weeks prior the start of the radiotherapy.
• •2. Patients who have had prior pelvic radiation therapy
• •3. Patients who have had prior treatment with taxanes
• •4. TURP within 3 months before start of the study
• •5. Patients who have had a prostatectomy.
• •6. Any contra-indication for MRI
• •7. Major difficulties for marker implantation
• •8. Unreliable contraceptive methods. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization)
• •9. Unresolved (\> grade 1) toxicities of previous chemotherapy, excluding alopecia.
• •10. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
• •11. Patients with a known history of hepatitis B or C;
• •12. Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician
• •13. Concomitant use of MDR and CYP3A modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analoga, or St. John's wort.
• •14. Pre-existing neuropathy greater than NCI-CTCAE v4.03 grade 1.
• •15. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance; Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
• •16. Legal incapacity