Prostate cancer is the most common non-skin tumor diagnosed in men and the second leading cause of cancer death in men in Western countries. Between 10-20% of patients are diagnosed at metastatic stage and about half of those diagnosed in early stages will develop metastases. After the clinical benefit of mitoxantrone and the improved survival of 2-3 months provided by docetaxel in first line, the second search is driven to look for effective second lines treatments. In recent years, there are new drugs for the treatment of prostate cancer, revolutionizing the therapeutic sequence and survival. Thus, androgen deprivation therapy, treatment of choice, induces an improvement of symptoms in approximately 70-80% of patients, but it is limited by the development of mechanisms of resistance to androgen deficiency. Docetaxel was the first chemotherapy drug to increase survival in patients with metastatic prostate cancer. The second cytotoxic drug approved in the second line treatment of metastatic CRPC has been cabazitaxel. Enzalutamide improves survival in patients with metastatic CRPC who had progressed to chemotherapy and also in patients who had not received chemotherapy. To date, there are no biomarkers available that allow us to identify which patients from a clinical or molecular view are those that will be able to benefit from the treatment options currently available. The presence of the TMPRSS2-ETS rearrangement has been shown to correlate with efficacy in clinical practice abiraterone. There is scientific and preclinical background that makes one suspect that the molecular alteration may influence the same way enzalutamide antiandrogen activity, but it has not been determined to date. The objective of this study is to determine whether the efficacy and safety of enzalutamide, when administered to patients with castration resistant prostate cancer prior to administration of docetaxel is influenced by the presence or absence of the fusion gene TMPRSS2- ETS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Enzalutamide 160 mg/day
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Hospital Parc Taulí
Barcelona, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, Spain
Complejo Asistencial Universitario de Leon
León, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 6 more locations
PSA progression free survival
Evaluate PSA progression (PCWG2 criteria) from date of patient inclusion until the date of first documented PSA progression or date of death from any cause, whichever came first, assessed up to 18 months.
Time frame: Up to 18 months
Number of individual events (hematologic events and not hematologic events) per patient
Number of events per patient
Time frame: Up to 12 months
Time to PSA response
Time from start of treatment to PSA progression (PCWG2 criteria)
Time frame: Up to 18 months
PSA response rate
PSA response according to PCWG2 criteria, as % of patients with PSA response
Time frame: Up to 18 months
Radiologic progression free survival
Radiologic progression free survival according RECIST 1.1 criteria, from date of patient inclusion until the date of first documented radiologic progression or date of death from any cause, whichever came first, assessed up to 18 months.
Time frame: Up to 18 months
Soft tissue response
Soft tissue response according RECIST 1.1 criteria
Time frame: Up to 18 months
Time until the beginning of cytotoxic chemotherapy
Time from date of patient inclusion until the date of the start of cytotoxic chemotherapy
Time frame: Up to 18 months
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