A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer (NCT01957436) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
Belgium1,173 participantsStarted 2013-11-13
Plain-language summary
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate,
✓. Metastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:
✓. Patients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),
✓. Life expectancy of at least 6 months,
✓. Male aged ≥ 18 years old and ≤ 80 years old ,
✓. Hematology values:
✓. Biochemistry values:
✓. Patients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,
Exclusion criteria
✕0. Patients might have received previous radiation therapy directed to bone lesions,
✕1. Patients able to take oral medication,
✕2. Patients who have received the information sheet and signed the informed consent form,
✕3. Male patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel
✕4. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
✕5. Patients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.
✕. Patients with previous definitive local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed,
✕. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,