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A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Castration Resistant Prostate Cancer

Intervention: Enzalutamide (Drug); Docetaxel (Drug); Prednisolone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Europe Ltd.

Overall contact:
Medical Affairs Europe, Phone: +44(0)20 3379 8000, Email: Astellas.registration@astellas.com

Summary

The purpose of the study is to understand if there is benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when treated with enzalutamide alone.

Clinical Details

Official title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Nave Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Progression free survival (PFS)

Secondary outcome:

Time to prostate-specific antigen (PSA) progression

PSA response

Objective response rate

Time to pain progression

Time to opiate use for cancer-related pain

Time to first skeletal-related event (SRE)

Quality of life

Detailed description: The study will be conducted in consecutive periods of open label treatment with enzalutamide followed by randomized double-blind treatment with continued enzalutamide or placebo, in combination with docetaxel and prednisolone. Open Label (Period 1) At Week 13, all subjects will be assessed by prostate-specific antigen (PSA) and imaging. Subjects with no confirmed PSA response or evidence of radiographic progression will be ineligible for participation in Period 2 and will typically have safety follow up; however, Period 1 treatment may continue for some subjects as long as the investigator considers it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Subjects with confirmed PSA response will continue Period 1 until disease progression. Randomization (Period 2) 274 subjects with confirmed disease progression on enzalutamide alone who continue to meet all eligibility criteria may proceed to randomization. Treatment allocation will be in a 1: 1 ratio, stratified by disease progression in Period 1 to the following treatments:

- Enzalutamide with docetaxel and prednisolone

- Placebo with docetaxel and prednisolone

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine

differentiation or small cell features;

- Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing

hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i. e., surgical or medical castration);

- Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue

disease documented by computed tomography (CT)/magnetic resonance imaging (MRI);

- Progressive disease at study entry defined as the following occurring in the setting

of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination.

- Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short

Form (BPI-SF) question 3 score of < 4);

- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;

- Estimated life expectancy of ≥ 12 months;

- Be suitable and willing to receive chemotherapy as part of the trial;

- Able to swallow the IMP and comply with study requirements;

- Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

- Prior treatment with the following agents for the treatment of prostate cancer:

Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an investigational agent that inhibits the AR or androgen synthesis unless the treatment was placebo;

- Current or prior treatment within 4 weeks prior to initiation of IMP with the

following agents for the treatment of prostate cancer: Antiandrogens; 5-α reductase inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties; Progestational agents;

- Subject has received investigational therapy within 28 days or 5 half-lives whichever

is longer, prior to initiation of IMP;

- Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to

initiation of IMP;

- Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation

of IMP;

- Major surgery within 4 weeks prior to initiation of IMP;

- History of seizure or any condition that may predispose to seizures at any time in

the past. History of loss of consciousness or transient ischemic attack within 12 months prior to Screening;

- Known or suspected brain metastasis or active leptomeningeal disease;

- History of another malignancy within the previous 5 years other than non-melanoma

skin cancer;

- Clinically significant cardiovascular disease;

- Gastrointestinal disorders affecting absorption;

- Medical contraindications to the use of prednisolone or docetaxel;

- Allergies to any of the active ingredients or excipients in the study drugs

Locations and Contacts

Medical Affairs Europe, Phone: +44(0)20 3379 8000, Email: Astellas.registration@astellas.com

Site: 43001, Wien 1090, Austria; Recruiting

Site: 32003, Bonheiden 2820, Belgium; Recruiting

Site: 32002, Liege 4000, Belgium; Recruiting

Site: 32004, Ottignies 1340, Belgium; Recruiting

Site: 32005, Turnhout 2300, Belgium; Recruiting

Site: 32008, Wilrijk 2610, Belgium; Recruiting

Site: 42004, Brno 656 91, Czech Republic; Recruiting

Site: 42003, Olomouc 77520, Czech Republic; Recruiting

Site: 42002, Plzeň 30460, Czech Republic; Recruiting

Site: 42001, Prague 12808, Czech Republic; Recruiting

Site: 33012, Albi 81000, France; Recruiting

Site: 33003, Montpellier 34298, France; Recruiting

Site: 33002, Nîmes 30907, France; Recruiting

Site: 33008, Paris 75014, France; Recruiting

Site: 33014, Paris 75014, France; Recruiting

Site: 33013, Quimper 29000, France; Recruiting

Site: 33011, Reims 51056, France; Recruiting

Site: 33004, Saint-Brieuc 22015, France; Recruiting

Site: 33005, Suresnes 92151, France; Recruiting

Site: 33006, Vandoeuvre les Nancy 54519, France; Withdrawn

Site: 49008, Aachen 52074, Germany; Recruiting

Site: 49010, Bergisch Gladbach 51465, Germany; Recruiting

Site: 49001, Hannover 30625, Germany; Recruiting

Site: 49006, Heidelberg 69120, Germany; Recruiting

Site: 49003, Mannheim 68167, Germany; Recruiting

Site: 49002, Muenster 48149, Germany; Recruiting

Site: 49018, Nuertingen 72622, Germany; Recruiting

Site: 49015, Tuebingen 72076, Germany; Recruiting

Site: 49017, Ulm 89075, Germany; Recruiting

Site: 49004, Wuppertal 42103, Germany; Recruiting

Site: 30003, Athens 14564, Greece; Recruiting

Site: 30001, Heraklion 71110, Greece; Recruiting

Site: 30004, Heraklion 71409, Greece; Recruiting

Site: 30002, Larissa 41110, Greece; Withdrawn

Site: 30005, Thessaloniki 54639, Greece; Recruiting

Site: 39001, Arezzo 52100, Italy; Recruiting

Site: 39012, Brescia 25123, Italy; Recruiting

Site: 39003, Milan 20100, Italy; Recruiting

Site: 39008, Naples 80131, Italy; Recruiting

Site: 39010, Pavia 27100, Italy; Recruiting

Site: 39004, Rome 00161, Italy; Recruiting

Site: 39005, Rome 00128, Italy; Recruiting

Site: 39002, Terni 05100, Italy; Recruiting

Site: 31004, Hoofddorp 2134, Netherlands; Recruiting

Site: 31003, Rotterdam 3045, Netherlands; Recruiting

Site: 31010, Utrecht 3543, Netherlands; Recruiting

Site: 47005, Drammen 3004, Norway; Recruiting

Site: 47001, Kristiansand 4615, Norway; Recruiting

Site: 47004, Stavanger 4011, Norway; Recruiting

Site: 48004, Gdansk 80-952, Poland; Recruiting

Site: 48003, Krakow 31-501, Poland; Recruiting

Site: 48002, Lodz 93-513, Poland; Recruiting

Site: 48005, Warszawa 04-141, Poland; Recruiting

Site: 48006, Warszawa 02-507, Poland; Recruiting

Site: 70001, Moscow 115478, Russian Federation; Recruiting

Site: 70005, St. Petersburg 197022, Russian Federation; Recruiting

Site: 34005, Lugo 27003, Spain; Recruiting

Site: 34001, Madrid 28040, Spain; Recruiting

Site: 34002, Madrid 28041, Spain; Recruiting

Site: 34003, Madrid 28007, Spain; Recruiting

Site: 34010, Madrid 28222, Spain; Recruiting

Site: 34007, Malaga 29010, Spain; Recruiting

Site: 34009, Murcia 30008, Spain; Recruiting

Site: 34008, Santander 39008, Spain; Recruiting

Site: 34004, Sevilla 41013, Spain; Recruiting

Site: 34006, Valencia 46009, Spain; Recruiting

Site: 46002, Göteborg 41345, Sweden; Recruiting

Site: 46005, Kalmar 39244, Sweden; Recruiting

Site: 46003, Solna 17176, Sweden; Recruiting

Site: 46004, Uppsala 75185, Sweden; Recruiting

Site: 90003, Istanbul 34722, Turkey; Recruiting

Site: 90002, Izmir 35340, Turkey; Recruiting

Site: 44010, Aberdeen AB25 2ZN, United Kingdom; Recruiting

Site: 44007, Bebington CH63 4JY, United Kingdom; Recruiting

Site: 44004, Cambridge CB2 0QQ, United Kingdom; Recruiting

Site: 44018, Cardiff CF14 2TL, United Kingdom; Recruiting

Site: 44014, Devon EX2 5DW, United Kingdom; Recruiting

Site: 44003, London SE1 9RT, United Kingdom; Recruiting

Site: 44020, Northwood HA6 2RN, United Kingdom; Recruiting

Site: 44015, Norwich NR4 7UY, United Kingdom; Recruiting

Site: 44002, Nottingham NG5 1PB, United Kingdom; Recruiting

Site: 44017, Swansea SA2 8QA, United Kingdom; Recruiting

Additional Information

Starting date: November 2014
Last updated: August 12, 2015

Page last updated: August 23, 2015

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