Study with Enzalutamide to understand molecular alterations in prostate cancer
Key facts
- Where
- Bilbao, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario BasurtoBilbao, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Trial code
- EU 2024-514786-19-01
- Record updated
- 2026. május 4.
- Original description
To study the molecular and cellular changes caused by Enzalutamide treatment as measured by receptor activity before and after Enzalutamide treatment.Read full original descriptionShow less
Translational research study to discover molecular changes in patients with localized prostate cancer undergoing robotic-assisted radical prostatectomy and treated for 4 weeks with Enzalutamide compared to those not treated with Enzalutamide
To study the molecular and cellular changes caused by Enzalutamide treatment as measured by receptor activity before and after Enzalutamide treatment.
Inclusion: Age over 18 years at the time of signing the informed consent form; Patients diagnosed with localized high-risk prostate cancer in whom radical prostatectomy indicated; Patients who decide surgery as curative intent for their pathology; Patients who sign the IC prior to any study-related activity, including the necessary screening evaluations.
Exclusion: 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; Having received previous treatment with hormones, Finasteride or Dutasteride before signing the informed consent; 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; Participation in another clinical trial where they have received an investigational drug in the 6 months prior to signing the informed consent; Patients diagnosed with non-high risk prostate cancer; Patients with active cancer in any other location; Men with pregnant partners who do not commit in writing to use a condom during the study and for up to 3 months afterwards; Patients who do not sign the informed consent form; Patients who are not going to undergo radical prostatectomy with robotic assistance; Inability to initiate treatment within the first week after signing the consent; 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.