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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103724
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma Prostate Drug: Xtandi Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : March 16, 2020
Estimated Study Completion Date : March 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: Enzalutamide


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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

  3. Pain assessment [ Time Frame: 2 years ]
    To evaluate pain as assessed by BPI-SF questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103724


Contacts
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Contact: Elena Verzoni, MD +390223904449 Elena.verzoni@istitutotumori.mi.it
Contact: Rosanna Montone, Dr.ssa +390223903817 Rosanna.montone@istitutotumori.mi.it

Locations
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Italy
Elena Verzoni Recruiting
Milan, Italy, 20133
Contact: Elena Verzoni, MD    +390223904449    Elena.verzoni@istitutotumori.mi.it   
Contact: Rosanna Montone, Dr.ssa    +390223903817    Rosanna.montone@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Elena Verzoni, MD Fondazione IRCCS Istituto Nazionale Tumori Milano
More Information
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Publications of Results:

Other Publications:
Astellas Pharma Ltd. Xtandi (enzalutamide) 40mg soft capsules. Summary of Product Characteristics. 26 June 2013.

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03103724    
Other Study ID Numbers: INT 178-15
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases