Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008812

Trial Description

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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

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Trial Acronym

PRESIDE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00008812
  •   2015/06/25
  •   2014/11/07
  •   no
  •   [---]*
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Secondary IDs

  •   2013-004711-50 
  •   NCT02288247  (ClinicalTrials.gov)
  •   9785-MA-1001  (Astellas Pharma Europe Ltd.)
  •   2013-004711-50 
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Health Condition or Problem studied

  •   Metastatic Castration Resistant Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Enzalutamide
  •   Drug: Docetaxel
  •   Drug: Prednisolone
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- 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)
- 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
- 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
- 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
- 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
- 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
- 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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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Czech Republic
  •   France
  •   Germany
  •   Greece
  •   Italy
  •   Netherlands
  •   Norway
  •   Poland
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/11/30
  •   650
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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Addresses

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    • Astellas Pharma Europe Ltd.
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    •   [---]*
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    • Medivation, Inc.
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Astellas Pharma Europe Ltd.
    • Medical Director 
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    • Medical Affairs Europe 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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  • Further contact 
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.