Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
30
Countries
1
Sites
1
PROSTATE CANCER
To study the molecular and cellular changes caused by Enzalutamide treatment as measured by receptor activity before and after Enzalutamide treatment.
Key facts
- Sponsor
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 27 Jan 2025 → ongoing
- Decision date (initial)
- 2024-09-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To study the molecular and cellular changes caused by Enzalutamide treatment as measured by receptor activity before and after Enzalutamide treatment.
Secondary objectives 3
- Change in cell proliferation and cell death before and after Enzalutamide treatment.
- Changes in gene expression before and after Enzalutamide treatment
- Changes in stromal composition before and after Enzalutamide treatment
Conditions and MedDRA coding
PROSTATE CANCER
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PROSEMA This is a “window of opportunity study” that offers the opportunity to understand the mechanism of action of the drug in a window after diagnosis and prior to treatment with curative intent.
|
2 | None | EXPERIMENTAL: Enzalutamida 40 MG CONTROL: WITHOUT MEDICATION |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514786-19-00 | 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 | Asociacion Instituto De Investigacion Sanitaria Biobizkaia |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 criteria 11
- Patients diagnosed with non-high risk prostate cancer.
- Patients who are not going to undergo radical prostatectomy with robotic assistance.
- Patients with active cancer in any other location
- 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
- Inability to initiate treatment within the first week after signing the consent
- Participation in another clinical trial where they have received an investigational drug in the 6 months prior to signing the informed 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- analyze molecular alterations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1863628 · Product
- Active substance
- Enzalutamide
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BB04 — -
- Marketing authorisation
- EU/1/13/846/001
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Sponsor organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Address
- Cruces Plaza 12
- City
- Barakaldo
- Postcode
- 48903
- Country
- Spain
Scientific contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- REGULATORIA
Public contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- REGULATORIA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-27 | 2025-02-05 | 2026-03-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo_C_v8_20241030 | 8 |
| Protocol (for publication) | D1_Protocolo_C_v8_20241030_CC | 8 |
| Recruitment arrangements (for publication) | CRD_PROSEMA | 1 |
| Recruitment arrangements (for publication) | K_Recruitment arrangment_E_V3 | 3 |
| Recruitment arrangements (for publication) | K_Recruitment arrangment_E_V3_CC | 3 |
| Recruitment arrangements (for publication) | Usual Practice Justification_2024-514786-19-00 | 1 |
| Subject information and informed consent form (for publication) | L1_PROSEMA_HIP_CI_V7_20241030 | 7 |
| Subject information and informed consent form (for publication) | PROSEMA_HIP_CI_V5_20240711_CC | 5 |
| Subject information and informed consent form (for publication) | PROSEMA_HIP_CI_V7_20241030_cc | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Enzalutamida | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS_E_V1 | 1 |
| Synopsis of the protocol (for publication) | D1_Resumen del Protocolo_C_V3_20240613 | 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Spain | Acceptable 2024-09-18
|
2024-09-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-04 | Spain | Acceptable 2025-01-08
|
2025-01-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-23 | Spain | Acceptable 2026-04-27
|
2026-05-04 |