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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 (PRESIDE)

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ClinicalTrials.gov Identifier: NCT02288247
Recruitment Status : Active, not recruiting
First Posted : November 11, 2014
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: Enzalutamide Drug: Docetaxel Drug: Prednisolone Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone
Actual Study Start Date : December 1, 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Enzalutamide with docetaxel + prednisolone
Continued treatment with enzalutamide after adding docetaxel and prednisolone
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi
  • ASP9785

Drug: Docetaxel
intravenous infusion

Drug: Prednisolone
Oral

Placebo Comparator: Placebo with docetaxel + prednisolone
Treatment with placebo after adding docetaxel and prednisolone
Drug: Docetaxel
intravenous infusion

Drug: Prednisolone
Oral

Drug: Placebo
Oral




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Until subject discontinuation (up to 3 years) ]
    PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression, unequivocal clinical progression, or death on study, whichever occurs first


Secondary Outcome Measures :
  1. Time to prostate-specific antigen (PSA) progression [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Time (in months) from randomization to the date of the first PSA value in Period 2 demonstrating progression (Period 2)

  2. PSA response [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Percentage change in PSA from randomization to Week 13 (or earlier for those that discontinue therapy), as well as the maximum decline in PSA that occurs at any point after treatment

  3. Objective response rate [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Best overall radiographic response after randomization as per the Investigator assessments of response for soft tissue disease per RECIST 1.1, in subjects who have a measurable tumor

  4. Time to pain progression [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Time (in months) to an increase of >= 30% from randomization in the mean of Brief Pain Inventory Short Form (BPI-SF) pain intensity item scores

  5. Time to opiate use for cancer-related pain [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Time (in months) to initiation of chronic administration of opiate analgesia

  6. Time to first skeletal-related event (SRE) [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Time (in months) from randomization to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain

  7. Quality of life [ Time Frame: Until subject discontinuation (up to 3 years) ]
    Assessed using Functional Assessment of Cancer Therapy - Prostate (FACT-P) and EuroQol 5 dimension, 5 level health state utility index (EQ-5D-5L)



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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:

  • 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

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): NCT02288247


  Hide Study Locations
Locations
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Austria
Site AT43004
Linz, Austria, 4010
Site AT43001
Vienna, Austria, 1090
Belgium
Site BE32003
Bonheiden, Belgium, 2820
Site BE32002
Liege, Belgium, 4000
Site BE32004
Ottignies, Belgium, 1340
Czechia
Site CZ42004
Brno, Czechia, 656 91
Site CZ42003
Olomouc, Czechia, 77520
Site CZ42002
Plzeň -Lochotín, Czechia, 30460
Site CZ42001
Praha 2, Czechia, 12808
France
Site FR33012
Albi, France, 81000
Site FR33003
Montpellier, France, 34298 cedex 5
Site FR33002
Nîmes, France, 30907 cedex 2
Site FR33008
Paris, France, 75014
Site FR33014
Paris, France, 75014
Site FR33004
Plerin, France, 22190
Site FR33013
Quimper, France, 29000
Site FR33011
Reims, France, 51056
Site FR33005
Suresnes, France, 92151
Germany
Site DE49018
Nürtingen, Baden-Württemberg, Germany, 72622
Site DE49008
Aachen, Germany, 52074
Site DE49010
Bergisch Gladbach, Germany, 51465
Site DE49001
Hannover, Germany, 30625
Site DE49006
Heidelberg, Germany, 69120
Site DE49003
Mannheim, Germany, 68167
Site DE49002
Munster, Germany, 48149
Site DE49015
Tübingen, Germany, 72076
Site DE49017
Ulm, Germany, 89075
Site DE49004
Wuppertal, Germany, 42103
Greece
Site GR30001
Heraklion, Crete, Greece, 70013
Site GR30004
Heraklion, Crete, Greece, 71403
Site GR30003
Athens, Greece, 14564
Site GR30006
Athens, Greece, 155 62
Site GR30005
Thessaloniki, Greece, 54007
Italy
Site IT39001
Arezzo, Italy, 52100
Site IT39012
Brescia, Italy, 25126
Site IT39003
Milano, Italy, 20100
Site IT39008
Naples, Italy, 80131
Site IT39010
Pavia, Italy, 27100
Site IT39005
Roma, Italy, 00128
Site IT39004
Rome, Italy, 161
Site IT39002
Terni, Italy, 05100
Netherlands
Site NL31002
Amsterdam, Netherlands, 1066 CX
Site NL31007
Blaricum, Netherlands, 1261 AN
Site NL31004
Hoofddorp, Netherlands, 2134 TM
Site NL31010
Nieuwegein, Netherlands, 3435 CM
Site NL31003
Rotterdam, Netherlands, 3045 PM
Norway
Site NO47005
Drammen, Norway, 3004
Site NO47001
Kristiansand, Norway, 4615
Site NO47004
Stavanger, Norway, 4011
Poland
Site PL48004
Gdańsk, Poland, 80-952
Site PL48003
Krakow, Poland, 31-501
Site PL48002
Lodz, Poland, 93-513
Site PL48006
Warszawa, Poland, 02-507
Site PL48005
Warszawa, Poland, 04-141
Russian Federation
Site RU70004
Obninsk, Kaluga, Russian Federation, 24903
Site RU70002
Moscow, Russian Federation, 105077
Site RU70001
Moscow, Russian Federation, 115478
Site RU70003
Moscow, Russian Federation, 125284
Site RU70005
St. Petersburg, Russian Federation, 197022
Site RU70006
St. Petersburg, Russian Federation, 197758
Spain
Site ES34005
Lugo, Spain, 27003
Site ES34003
Madrid, Spain, 28007
Site ES34001
Madrid, Spain, 28040
Site ES34002
Madrid, Spain, 28041
Site ES34010
Madrid, Spain
Site ES34007
Malaga, Spain, 29010
Site ES34009
Murcia, Spain, 30008
Site ES34008
Santander, Spain, 39008
Site ES34004
Sevilla, Spain, 41013
Site ES34006
Valencia, Spain, 46009
Sweden
Site SE46002
Göteborg, Sweden, 413 45
Site SE46005
Kalmar, Sweden, 39185
Site SE46003
Solna, Sweden, 171 76
Site SE46004
Uppsala, Sweden, 751 85
Switzerland
Site CH41005
Locarno, Tessin, Switzerland, 6600
Site CH41009
Zurich, Switzerland, CH-8038
Turkey
Site TR90001
Ankara, Turkey, 06500
Site TR90003
Istanbul, Turkey, 34722
Site TR90002
Izmir, Turkey, 35340
United Kingdom
Site GB44010
Aberdeen, United Kingdom, AB25 2ZN
Site GB44004
Cambridge, United Kingdom, CB2 0QQ
Site GB44018
Cardiff, United Kingdom, CF4 7XL
Site GB44014
Exeter, United Kingdom
Site GB44003
London, United Kingdom, SE1 9RT
Site GB44020
Northwood, United Kingdom, HA62RN
Site GB44015
Norwich, United Kingdom, NR4 7UY
Site GB44002
Nottingham, United Kingdom, NG5 1PB
Site GB44017
Swansea, United Kingdom, SA2 8QA
Site GB44007
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Medivation, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Europe Ltd.

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Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT02288247     History of Changes
Other Study ID Numbers: 9785-MA-1001
2013-004711-50 ( EudraCT Number )
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Metastatic
Castration-resistant
Docetaxel
Chemotherapy- Naïve
Enzalutamide
Prostate Cancer
Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer
Prednisolone
Xtandi
Metastatic Castration Resistant Prostate Cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents