Enzalutamide for Prostate cancer | Localized high-risk prostate cancer

Inclusion criteria

• {"criterion_text":"- Age over 18 years at the time of signing the informed consent form\n- Patients diagnosed with localized high-risk prostate cancer in whom radical prostatectomy indicated.\n- Patients who decide surgery as curative intent for their pathology\n- Patients who sign the IC prior to any study-related activity, including the necessary screening evaluations"}

Exclusion criteria

• {"criterion_text":"- Patients diagnosed with non-high risk prostate cancer.\n- Men with pregnant partners who do not commit in writing to use a condom during the study and for up to 3 months afterwards\n- Patients who do not sign the informed consent form\n- Patients who are not going to undergo radical prostatectomy with robotic assistance.\n- Patients with active cancer in any other location\n- Diagnosis of any other pathology that in the investigator's opinion may increase the subject's risk or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.\n- Having received previous treatment with hormones, Finasteride or Dutasteride before signing the informed consent\n- Contraindication due to potential interactions of their usual treatment with Enzalutamide or for any other cause in the investigator's judgment such as difficulty swallowing\n- Inability to initiate treatment within the first week after signing the consent\n- Participation in another clinical trial where they have received an investigational drug in the 6 months prior to signing the informed consent\n- Men with partners physiologically capable of becoming pregnant who do not commit in writing to use, during their participation in the study and up to 3 months after the end of the study, a reliable method of contraception. Men must also use a condom-type barrier method for the same period of time"}

Primary endpoints

• {"endpoint_text":"- analyze molecular alterations","definition_or_measurement_approach":"To study the molecular and cellular changes caused by Enzalutamide treatment as measured by receptor activity before and after Enzalutamide treatment."}

Spain

Earliest CTIS Part Ii Submission Date

26-07-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

647

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain