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 : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration Resistant Prostate Cancer||Drug: Enzalutamide Drug: Docetaxel Drug: Prednisolone Drug: Placebo||Phase 3|
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)
Participants will receive open label treatment with enzalutamide. At week 13, all participants will be assessed by prostate-specific antigen (PSA) and imaging. Participants 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 participants as long as the investigator considers it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Participants with confirmed PSA response will continue Period 1 until disease progression.
Enrollment to Period 2 will cease after approximately 274 participants have been enrolled or 182 primary endpoint events have been reached, whichever occurs first. Participants who are not randomized into period 2 at this time may continue receiving open label treatment in an extension period.
Randomization (Double Blind) (Period 2)
Participants 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
Any ongoing participants in Period 2 at the point of unblinding in the enzalutamide+docetaxel arm that are still receiving and benefitting from enzalutamide treatment , will have the option to continue treatment via an extension period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||690 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Enzalutamide with docetaxel + prednisolone
Continued treatment with enzalutamide after adding docetaxel and prednisolone
Placebo Comparator: Placebo with docetaxel + prednisolone
Treatment with placebo after adding docetaxel and prednisolone
- 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
- Time to prostate-specific antigen (PSA) progression [ Time Frame: Until subject discontinuation (up to 5 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 5 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 5 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 5 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 5 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 5 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 as assessed Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: Until subject discontinuation (up to 5 years) ]The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: physical, social/family, emotional, and functional well-being, which is further supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score with higher scores representing better quality of life.
- Quality of life assessed using EuroQol 5 dimension, 5 level health state utility index (EQ-5D-5L) [ Time Frame: Until subject discontinuation (up to 5 years) ]EQ-5D-5L is designed for self-completion by respondents. It consists of 2 pages comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels and the subject is asked to indicate his health state by ticking the box with the most appropriate statement.
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
|Study Director:||Medical Director||Astellas Pharma Europe Ltd.|