Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading cause of men cancer death in the United States. Hormonal therapy remains a first-line treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical or surgical castration are quite favorable, however, most patients will progress to a castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option for patients with mCRPC. Abiraterone is a novel, selective, irreversible, and potent inhibitor of 17-\[alpha\]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been demonstrated to further reduce testosterone levels in the blood to undetectable range (\< 1 ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone demonstrated activity in castration resistant prostate cancer patients previously treated with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis, castration-resistant metastatic prostate cancer patients, demonstrated a better radiological progression free survival for abiraterone treated patients and a trend towards a better survival was clear for abiraterone treated patients. No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy combination. All trials have been performed in patients in which LHRH agonist treatment was continued although there is not clear evidence about efficacy of hormonal treatment. Some retrospective studies suggest that androgen deprivation treatment should be maintained in chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to negative values, and to add efficacy to castration hormonal therapy. Combination of abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.
Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
...and 7 more locations
1 year radiologic progression free survival
Time from randomization to radiologic disease progression
Time frame: 1 year
Overall survival
Time from randomization to death
Time frame: Up to 3 years
Radiologic progression free survival
Time from randomization to radiologic progression free survival
Time frame: Up to 1 year
PSA progression free survival
Time from randomization to PSA progression
Time frame: Up to 3 weeks
PSA response rate
50% \& 90% PSA reduction from randomisation
Time frame: Up to 3 weeks
Objective response rate
Response according RECIST criteria
Time frame: Up to 12 weeks
Quality of life rate
Quality of life according to FACT-P questionaire
Time frame: Up to 12 weeks
Time to skeletal-related event
Time from randomization to skeletal-related events
Time frame: Up to 12 weeks
Time to opiate use for cancer pain
Time from randomization to opiate use for cancer pain
Time frame: Up to 3 weeks
Time to pain progression
Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline
Time frame: Up to 3 weeks
Safety profile
Related adverse events per patient
Time frame: Up to 3 weeks
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