Study evaluating efficacy of enzalutamide and variants of androgens receptor in metastatic castration resistant prostate cancer patients with visceral disease

A phase II study evaluating the efficacy of enzalutamide and the role of ARv7 in metastatic castration resistant prostate cancer (mCRPC) patients with visceral disease - EXCALIBUR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004596-72-IT

Enrollment

Registered

2021-02-09

Start date

2016-04-06

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic prostate cancer resistant to castration with visceral disease MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 100000004864

Interventions

Trade Name: XTANDI - "40 MG - CAPSULA MOLLE - USO ORALE - BLISTER (PVC/PCTFE/ALU)" 112 CAPSULE Product Name: Xtandi Product Code: [Xtandi] Pharmaceutical Form: Capsule, soft INN or Proposed INN: ENZAL

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma - Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria) - Life expectancy > 3 months - Patients may have received previous therapy including chemotherapy (including docetaxel) - Progressive disease by PSA or imaging in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria (according with PCWG2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Metastases in the brain or active epidural disease - History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer - Prior treatment with abiraterone acetate - Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride)

Design outcomes

Primary

Measure	Time frame
Main Objective: Clinical benefit, in terms of disease control at 3 months (DCR) of Enzalutamide in patients with cancer castration resistant prostate cancer with the presence ofvisceral disease;Secondary Objective: Evaluate the safety profile of the treatment; Assess the quality of life through specific questionnaires such as EQ-5D-5L and FACT-P; Assess pain using the BPI-SF questionnaire;Primary end point(s): The primary endpoint is 3 months DCR;Timepoint(s) of evaluation of this end point: 3 month	—

Measure

Time frame

Main Objective: Clinical benefit, in terms of disease control at 3 months (DCR) of Enzalutamide in patients with cancer castration resistant prostate cancer with the presence ofvisceral disease;Secondary Objective: Evaluate the safety profile of the treatment; Assess the quality of life through specific questionnaires such as EQ-5D-5L and FACT-P; Assess pain using the BPI-SF questionnaire;Primary end point(s): The primary endpoint is 3 months DCR;Timepoint(s) of evaluation of this end point: 3 month

—

Secondary

Measure	Time frame
Secondary end point(s): - To determine the safety of the treatment - to evaluate quality of life according EQ-5D-5L e FACT-P - to evaluate pain according to BPI-SF;Timepoint(s) of evaluation of this end point: end of study	—

Countries

Italy

Contacts

Public Contactclinical trial center

Fondazione IRCCS Istituto Nazionale Tumori

trialcenter@istitutotumori.mi.it0223903817

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026