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)

April 23, 2021 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Open label, single arm, phase II multicentre study designed to determine the clinical benefit, as measured by 3-months disease control rate (DCR) provided by enzalutamide in metastatic Castration Resistant Prostate Cancer patients with at least one visceral site involvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Elena Verzoni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age > 18
  2. ECOG PS 0-1-2
  3. Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma
  4. Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria) considering metastases in lung or liver or extraregional lymphnodes
  5. Written informed consent
  6. Platelets > or = 100 x109/L; haemoglobin > or = 9 g/dl; neutrophils > or 1.5 x 109/L
  7. Bilirubin < or = 2 mg/dl, AST and ALT < or = 2.5 times the UNL or < or = 5 times UNL for pts with liver metastases; serum albumin > or = the LNL
  8. Patients of childbearing age should use contraceptive methods
  9. Life expectancy > 3 months
  10. Able to swallow the study drug and comply with study requirements;
  11. Willing and able to give informed consent.
  12. Ongoing androgen deprivation therapy with a GnRH analogue or orchiectomy (i.e., surgical or medical castration);
  13. Patients may have received previous therapy including chemotherapy (docetaxel) last cycle must be received 3 weeks before start of experimental treatment. Hormonal treatment containing bicalutamide must be interrupted 2 weeks before start of study therapy
  14. Previous radiotherapy (prostate and/or bone) is accepted but must be interrupted 3 weeks before start of experimental treatment.
  15. Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit

  16. 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):

    • PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 g/L (2 ng/ml); if the third PSA value is less than second PSA, a fourth PSA must be repeated and if it the value is higher than second must be considered as disease
    • Soft tissue/visceral disease progression defined by RECIST 1.1;
    • Bone disease progression defined by two or more new lesions on bone scan.

Exclusion Criteria:

  1. Severe, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
  2. Metastases in the brain or active epidural disease;
  3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer;
  4. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months of enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, head trauma with loss of consciousness requiring hospitalization);
  5. Clinically significant cardiovascular disease including: Myocardial infarction within 6 months; Uncontrolled angina within 3 months; Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%;
  6. Diagnosed or suspected congenital long QT syndrome;
  7. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  8. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer within last 3 months);
  9. Major surgery within 4 weeks prior to enrollment (Day 1 visit);
  10. Prior treatment with abiraterone acetate;
  11. Participation in a clinical trial about an experimental anti-androgen agent (eg. ARN-509, ODM-201, VT-464, except for placebo arm);
  12. Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enzalutamide
All subjects will receive open label enzalutamide 160 mg (4 x 40 mg capsules), orally once daily.
Drug: Xtandi
Enzalutamide 160 mg (4 x 40 mg capsules), orally once daily
Other Names:
  • Enzalutamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 3 months
To determine the clinical benefit, as measured by 3 months disease control rate (DCR) provided by enzalutamide in mCRPC patients with visceral disease.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the treatment per NCI-CTCA v. 4.0
Time Frame: 2 years
To determine the safety of the treatment according to NCI-CTCA v. 4.0
2 years
Quality of life by EQ-5D-5L e FACT-P
Time Frame: 2 years
To evaluate quality of life as assessed by EQ-5D-5L e FACT-P questionnaire
2 years
Pain assessment
Time Frame: 2 years
To evaluate pain as assessed by BPI-SF questionnaire
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Elena Verzoni, MD, Fondazione IRCCS Istituto Nazionale Tumori Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 178-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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