A Phase 3 interventional study of Enzalutamide and Docetaxel in Metastatic Castration Resistant Prostate Cancer, sponsored by Astellas Pharma Europe Ltd.. Completed at 89 sites in 16 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
The purpose of the study was to understand if there was 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 had gotten worse when treated with enzalutamide alone.
The study was 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 received open label treatment (OL) with enzalutamide. At week 13, all participants were assessed by prostate-specific antigen (PSA) and imaging. Participants with no confirmed PSA response or evidence of radiographic progression were ineligible for participation in Period 2 and typically had safety follow up; however, Period 1 treatment continued for some participants as long as the investigator considered it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Participants with confirmed PSA response continued Period 1 until disease progression.
Enrollment to Period 2 ceased after approximately 274 participants had been enrolled or 182 primary endpoint events had been reached, whichever occurred first. Participants who were not randomized into period 2 at this time continued to receive open label treatment in an extension period.
Randomization (Double Blind [DB]) (Period 2)
Participants with confirmed disease progression on enzalutamide alone who continued to meet all eligibility criteria proceeded to randomization. Treatment allocation was in a 1:1 ratio, stratified by disease progression in Period 1 to the following treatments:
Any ongoing participants in Period 2 at the point of unblinding in the enzalutamide+docetaxel arm that were still receiving and benefitting from enzalutamide treatment, had the option to continue treatment via an extension period.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 688 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants (Pts) received OL enzalutamide 160 mg QD from Day 1 in Period 1 (P1) until they were either randomized to Period 2 (P2), were ineligible, experienced intolerable toxicity, withdrew, or died. Pts with confirmed disease progression in P1, meeting eligibility, were randomized to receive placebo/enzalutamide 160 mg QD with docetaxel 75 mg/m\^2 in 1hour infusion every 3 weeks \& prednisolone 5mg twice daily in P2. Docetaxel \& prednisolone were administered for upto 10 cycles (1 cycle=3 weeks) or more per investigator discretion, while placebo/enzalutamide continued until progression, toxicity, withdrawal, or death. Extension(EXT) phase was available for Pts in P1\& P2 who were not meeting primary endpoint. Enzalutamide continued until disease progression, intolerable toxicity, withdrawal, or death. Pts not entering EXT discontinued and received local care. Those benefiting from enzalutamide in EXT at study closure continued in study 9785-CL-0123 or via commercial enzalutamide.
Drug: Enzalutamide · Drug: Docetaxel · Drug: Prednisolone
Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m\^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle = 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants discontinued the study and received local standard of care.
Drug: Docetaxel · Drug: Prednisolone · Drug: Placebo
Oral
Also known as: Xtandi, ASP9785
intravenous infusion
Oral
Oral
Progression Free Survival (PFS)
PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression.
Time frame: From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later.
Time frame: From date of randomization to the first PSA value (median duration: 35 weeks)
Prostate-specific Antigen (PSA) Response
PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported.
Time frame: Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)
Objective Response Rate (ORR)
ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
Time frame: From date of randomization up to median duration of 35 weeks
Time to Pain Progression
The time to an increase of \>=30% from randomization (Period 2 Week 1) in average BPI-SF item scores (items 3, 4, 5, 6) at two consecutive evaluations \>=3 weeks apart without decrease in analgesic score according to the World health Organization (WHO). Only participants with an average pain intensity item score \>=4 were considered. The BPI-SF was an instrument to document pain-related functional impairment and contains 7 questions which included pain intensity \[(items 3, 4, 5 and 6): worst pain, least pain, average pain and current pain, with scales from 0 (no pain) to 10 (pain as bad as you can imagine)\] and pain interference \](items 9A to 9G): general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with scales from 0 (does not interfere) to 10 (completely interferes)\]. The BPI-SF total score for pain intensity was calculated as the mean of the 4 scores for the 4 items of pain intensity.
Time frame: From date of randomization up to median duration of 35 weeks
Time to Opiate Use for Cancer-related Pain
Time to opiate use for cancer-related pain, defined as the time from randomization (Period 2 Week 1) to initiation of chronic administration of opiate analgesia \[parenteral opiate use for ≥7 days or use of WHO Analgesic Ladder Level 3 oral opiates for ≥3 weeks\].
Time frame: From date of randomization up to median duration of 35 weeks
Time to First Skeletal-related Event (SRE)
Time to first SRE, defined as the time from randomization (Period 2 Week 1) to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.
Time frame: From date of randomization up to median duration of 35 weeks
Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)
FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), social/family well-being (SWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), emotional well-being (EWB) (6 items; 0 \[worst\] to 4 \[better\], score range 0-24), and functional well-being (FWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale \[PCS\] 12 items rated on Likert-type scale 0 \[worst\] to 4 \[better\], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life.
Time frame: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181
Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable).
Time frame: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181
Male participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who had progressed while on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy and had not yet received chemotherapy were enrolled in the study.
| Milestone | Enzalutamide | Placebo |
|---|---|---|
| Started | 688 | 0 |
| Treated | 687 | 0 |
| Completed | 0 | 0 |
| Not completed | 688 | 0 |
| Withdrew: Adverse event | 52 | 0 |
| Withdrew: Death | 35 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Progressive disease | 393 | 0 |
| Withdrew: Protocol violation | 9 | 0 |
| Withdrew: Withdrawal by subject | 54 | 0 |
| Withdrew: Other | 142 | 0 |
| Withdrew: Study terminated by sponsor | 2 | 0 |
| Milestone | Enzalutamide | Placebo |
|---|---|---|
| Started | 137 | 136 |
| Treated | 136 | 135 |
| Completed | 0 | 1 |
| Not completed | 137 | 135 |
| Withdrew: Adverse event | 10 | 8 |
| Withdrew: Death | 8 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Progressive disease | 87 | 94 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 7 | 7 |
| Withdrew: Other | 21 | 21 |
| Withdrew: Randomized but not treated | 1 | 0 |
PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression.
| months | Enzalutamide | Placebo |
|---|---|---|
| Progression Free Survival (PFS) | 9.53 (8.25 to 10.87) | 8.28 (6.28 to 8.71) |
Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later.
| months | Enzalutamide | Placebo |
|---|---|---|
| Time to Prostate-specific Antigen (PSA) Progression | 8.44 (8.18 to 9.00) | 6.24 (5.42 to 8.31) |
PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported.
| percentage of participants | Enzalutamide | Placebo |
|---|---|---|
| Week 13 | 44.9 | 25.2 |
| Any time after randomization (median of 35 weeks) | 55.9 | 37.0 |
ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
| percentage of participants | Enzalutamide | Placebo |
|---|---|---|
| Objective Response Rate (ORR) | 31.6 (0.60 to 0.76) | 25.9 (0.66 to 0.81) |
The time to an increase of \>=30% from randomization (Period 2 Week 1) in average BPI-SF item scores (items 3, 4, 5, 6) at two consecutive evaluations \>=3 weeks apart without decrease in analgesic score according to the World health Organization (WHO). Only participants with an average pain intensity item score \>=4 were considered. The BPI-SF was an instrument to document pain-related functional impairment and contains 7 questions which included pain intensity \[(items 3, 4, 5 and 6): worst pain, least pain, average pain and current pain, with scales from 0 (no pain) to 10 (pain as bad as you can imagine)\] and pain interference \](items 9A to 9G): general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with scales from 0 (does not interfere) to 10 (completely interferes)\]. The BPI-SF total score for pain intensity was calculated as the mean of the 4 scores for the 4 items of pain intensity.
No measurements were reported for this outcome.
Time to opiate use for cancer-related pain, defined as the time from randomization (Period 2 Week 1) to initiation of chronic administration of opiate analgesia \[parenteral opiate use for ≥7 days or use of WHO Analgesic Ladder Level 3 oral opiates for ≥3 weeks\].
No measurements were reported for this outcome.
Time to first SRE, defined as the time from randomization (Period 2 Week 1) to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.
| months | Enzalutamide | Placebo |
|---|---|---|
| Time to First Skeletal-related Event (SRE) | 21.98 (15.18 to NA) | 17.35 (17.35 to NA) |
FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), social/family well-being (SWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), emotional well-being (EWB) (6 items; 0 \[worst\] to 4 \[better\], score range 0-24), and functional well-being (FWB) (7 items; 0 \[worst\] to 4 \[better\], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale \[PCS\] 12 items rated on Likert-type scale 0 \[worst\] to 4 \[better\], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life.
| score on a scale | Enzalutamide | Placebo |
|---|---|---|
| EWB: Baseline | 0.00 ± 0.00 | 0.00 ± 0.00 |
| EWB: Change at Week 1 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| EWB: Change at Week 13 | 1.15 ± 4.15 | 1.36 ± 3.63 |
| EWB: Change at Week 25 | 0.69 ± 3.85 | 1.03 ± 3.58 |
| EWB: Change at Week 37 | 1.91 ± 3.85 | 1.43 ± 3.73 |
| EWB: Change at Week 49 | 1.22 ± 3.62 | 0.73 ± 4.24 |
| EWB: Change at Week 61 | 0.59 ± 4.52 | 2.00 ± 3.58 |
| EWB: Change at Week 73 | 1.69 ± 3.13 | -1.00 |
| EWB: Change at Week 85 | 1.00 ± 4.06 | -5.00 |
| EWB: Change at Week 97 | 3.90 ± 4.75 | — |
| EWB: Change at Week 109 | 2.93 ± 3.49 | — |
| EWB: Change at Week 121 | 4.00 ± 2.83 | — |
| EWB: Change at Week 133 | 2.00 ± 0.00 | — |
| EWB: Change at Week 145 | 2.00 | — |
| EWB: Change at Week 157 | 2.00 | — |
| EWB: Change at Week 169 | 1.00 | — |
| EWB: Change at Week 181 | 2.00 | — |
| FWB: Baseline | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| FWB: Change at Week 1 | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| FWB: Change at Week 13 | -1.8144 ± 5.0586 | -0.3121 ± 4.7437 |
| FWB: Change at Week 25 | -2.4472 ± 5.2508 | -0.8229 ± 5.2563 |
| FWB: Change at Week 37 | -1.5697 ± 6.3251 | -0.1459 ± 3.2857 |
| FWB: Change at Week 49 | -1.1579 ± 6.7284 | -1.3818 ± 4.5238 |
| FWB: Change at Week 61 | 0.0000 ± 4.7651 | -2.3333 ± 2.8048 |
| FWB: Change at Week 73 | -1.8182 ± 3.5726 | -2.0000 |
| FWB: Change at Week 85 | 1.2000 ± 4.8166 | 0.0000 |
| FWB: Change at Week 97 | -0.5000 ± 1.7321 | — |
| FWB: Change at Week 109 | -1.3333 ± 3.2146 | — |
| FWB: Change at Week 121 | -1.5000 ± 0.7071 | — |
| FWB: Change at Week 133 | -0.5000 ± 2.1213 | — |
| FWB: Change at Week 145 | -2.0000 | — |
| FWB: Change at Week 157 | 0.0000 | — |
| FWB: Change at Week 169 | -1.0000 | — |
| FWB: Change at Week 181 | 0.0000 | — |
| Global Score: Baseline | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| Global Score: Change at Week 1 | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| Global Score: Change at Week 13 | -0.7836 ± 17.7356 | 1.7986 ± 16.3294 |
| Global Score: Change at Week 25 | -5.9204 ± 18.2107 | 1.0762 ± 17.0168 |
| Global Score: Change at Week 37 | -1.5351 ± 20.3721 | 0.1649 ± 15.8335 |
| Global Score: Change at Week 49 | -4.4880 ± 24.6865 | -4.6202 ± 17.9530 |
| Global Score: Change at Week 61 | -0.2957 ± 17.6915 | 6.0939 ± 8.8208 |
| Global Score: Change at Week 73 | -0.3917 ± 18.3346 | — |
| Global Score: Change at Week 85 | 1.7636 ± 11.7476 | — |
| Global Score: Change at Week 97 | 6.2864 ± 9.8128 | — |
| Global Score: Change at Week 109 | -2.7333 ± 17.6299 | — |
| Global Score: Change at Week 121 | 4.0000 | — |
| Global Score: Change at Week 133 | -7.0000 ± 4.2426 | — |
| Global Score: Change at Week 145 | -11.0000 | — |
| Global Score: Change at Week 157 | -1.0000 | — |
| Global Score: Change at Week 169 | -10.0000 | — |
| Global Score: Change at Week 181 | -4.0000 | — |
| PWB: Baseline | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| PWB: Change at Week 1 | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| PWB: Change at Week 13 | -1.3322 ± 6.0823 | -0.6347 ± 4.4643 |
| PWB: Change at Week 25 | -3.1317 ± 6.5208 | -0.4590 ± 4.2887 |
| PWB: Change at Week 37 | -2.1786 ± 5.5611 | -0.9556 ± 4.3691 |
| PWB: Change at Week 49 | -2.5316 ± 8.0882 | -1.3913 ± 6.1625 |
| PWB: Change at Week 61 | -1.3889 ± 6.9886 | 1.3333 ± 3.8297 |
| PWB: Change at Week 73 | -0.3636 ± 8.0408 | 3.0000 |
| PWB: Change at Week 85 | 1.0000 ± 10.3682 | 3.0000 |
| PWB: Change at Week 97 | 1.7500 ± 10.4363 | — |
| PWB: Change at Week 109 | -0.6667 ± 13.6504 | — |
| PWB: Change at Week 121 | -4.0000 ± 1.4142 | — |
| PWB: Change at Week 133 | -4.5000 ± 0.7071 | — |
| PWB: Change at Week 145 | -4.0000 | — |
| PWB: Change at Week 157 | 0.0000 | — |
| PWB: Change at Week 169 | -4.0000 | — |
| PWB: Change at Week 181 | -2.0000 | — |
| PCS: Baseline | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| PCS: Change at Week 1 | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| PCS: Change at Week 13 | 1.1842 ± 6.1843 | 1.6011 ± 6.0731 |
| PCS: Change at Week 25 | -0.4775 ± 6.2665 | 1.8632 ± 6.3433 |
| PCS: Change at Week 37 | -1.1433 ± 7.3006 | 0.6988 ± 7.1353 |
| PCS: Change at Week 49 | -1.8465 ± 8.6083 | -0.7223 ± 7.8442 |
| PCS: Change at Week 61 | 0.3690 ± 6.0031 | 4.2606 ± 3.1148 |
| PCS: Change at Week 73 | 0.9174 ± 7.8001 | — |
| PCS: Change at Week 85 | 2.1636 ± 5.6123 | — |
| PCS: Change at Week 97 | 3.8864 ± 3.3380 | — |
| PCS: Change at Week 109 | -1.6667 ± 5.8595 | — |
| PCS: Change at Week 121 | 2.0000 | — |
| PCS: Change at Week 133 | -3.0000 ± 4.2426 | — |
| PCS: Change at Week 145 | -5.0000 | — |
| PCS: Change at Week 157 | 0.0000 | — |
| PCS: Change at Week 169 | -3.0000 | — |
| PCS: Change at Week 181 | -2.0000 | — |
| SWB: Baseline | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| SWB: Change at Week 1 | 0.0000 ± 0.0000 | 0.0000 ± 0.0000 |
| SWB: Change at Week 13 | -0.1581 ± 4.1893 | -0.2953 ± 5.0738 |
| SWB: Change at Week 25 | -0.3634 ± 5.6959 | -0.0462 ± 3.7933 |
| SWB: Change at Week 37 | 0.8798 ± 4.6897 | -0.3963 ± 3.3279 |
| SWB: Change at Week 49 | -0.0719 ± 6.2561 | -0.7536 ± 4.3164 |
| SWB: Change at Week 61 | -0.8167 ± 3.3323 | 0.8333 ± 5.7067 |
| SWB: Change at Week 73 | -0.8182 ± 2.7863 | -24.0000 |
| SWB: Change at Week 85 | -3.6000 ± 3.7815 | -24.0000 |
| SWB: Change at Week 97 | -2.7500 ± 5.8523 | — |
| SWB: Change at Week 109 | -2.0000 ± 4.3589 | — |
| SWB: Change at Week 121 | 0.5000 ± 0.7071 | — |
| SWB: Change at Week 133 | -1.0000 ± 1.4142 | — |
| SWB: Change at Week 145 | -2.0000 | — |
| SWB: Change at Week 157 | -3.0000 | — |
| SWB: Change at Week 169 | -3.0000 | — |
| SWB: Change at Week 181 | -2.0000 | — |
The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable).
| score on a scale | Enzalutamide | Placebo |
|---|---|---|
| Baseline | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Change at Week 1 | 0.0 ± 0.0 | 0.0 ± 0.0 |
| Change at Week 13 | 2.3 ± 19.7 | -0.8 ± 17.8 |
| Change at Week 25 | -3.0 ± 18.6 | -0.2 ± 17.7 |
| Change at Week 37 | -1.3 ± 21.7 | 0.4 ± 15.8 |
| Change at Week 49 | -2.5 ± 25.7 | -8.3 ± 23.3 |
| Change at Week 61 | 1.3 ± 22.6 | 2.5 ± 25.2 |
| Change at Week 73 | -3.5 ± 30.8 | -20.0 |
| Change at Week 85 | 7.2 ± 20.7 | -10.0 |
| Change at Week 97 | 17.8 ± 27.0 | — |
| Change at Week 109 | 17.7 ± 23.6 | — |
| Change at Week 121 | -7.0 ± 4.2 | — |
| Change at Week 133 | 0.5 ± 13.4 | — |
| Change at Week 145 | 1.0 | — |
| Change at Week 157 | -4.0 | — |
| Change at Week 169 | 2.0 | — |
| Change at Week 181 | -4.0 | — |
Collected over From first dose up to 71 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Enzalutamide | 51/687 (7.4%) | 238/687 (34.6%) | 523/687 (76.1%) |
| Period 2: Enzalutamide | 18/136 (13.2%) | 67/136 (49.3%) | 125/136 (91.9%) |
| Period 2: Placebo | 15/135 (11.1%) | 52/135 (38.5%) | 123/135 (91.1%) |
| Event | Period 1: Enzalutamide | Period 2: Enzalutamide | Period 2: Placebo |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/687 | 10/136 | 15/135 |
| NeutropeniaBlood and lymphatic system disorders | 0/687 | 11/136 | 5/135 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 22/687 | 6/136 | 6/135 |
| PyrexiaGeneral disorders | 2/687 | 6/136 | 2/135 |
| Neutropenic sepsisInfections and infestations | 1/687 | 5/136 | 3/135 |
| Spinal cord compressionNervous system disorders | 6/687 | 5/136 | 1/135 |
| PneumoniaInfections and infestations | 5/687 | 4/136 | 3/135 |
| DiarrhoeaGastrointestinal disorders | 1/687 | 1/136 | 3/135 |
| General physical health deteriorationGeneral disorders | 5/687 | 1/136 | 3/135 |
| Back painMusculoskeletal and connective tissue disorders | 12/687 | 2/136 | 3/135 |
| Event | Period 1: Enzalutamide | Period 2: Enzalutamide | Period 2: Placebo |
|---|---|---|---|
| AstheniaGeneral disorders | 109/687 | 46/136 | 35/135 |
| AlopeciaSkin and subcutaneous tissue disorders | 2/687 | 44/136 | 37/135 |
| NeutropeniaBlood and lymphatic system disorders | 5/687 | 41/136 | 43/135 |
| DiarrhoeaGastrointestinal disorders | 63/687 | 37/136 | 42/135 |
| FatigueGeneral disorders | 159/687 | 40/136 | 28/135 |
| AnaemiaBlood and lymphatic system disorders | 49/687 | 27/136 | 15/135 |
| NauseaGastrointestinal disorders | 69/687 | 26/136 | 25/135 |
| Lacrimation increasedEye disorders | 2/687 | 25/136 | 6/135 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 70/687 | 25/136 | 10/135 |
| Back painMusculoskeletal and connective tissue disorders | 117/687 | 13/136 | 14/135 |
Safety Analysis Set 1 (SAF1) included all participants who received at least one dose of investigational medicinal product (IMP) in period 1.
| Age, Continuous(years) | Enzalutamide |
|---|---|
| Mean | 71.0 ± 7.8 |
| Sex: Female, Male(Participants) | Enzalutamide |
|---|---|
| Female | 0 |
| Male | 687 |
| Race/Ethnicity, Customized(participants) | Enzalutamide |
|---|---|
| Race : White | 681 |
| Race : Black Or African American | 5 |
| Race : Other | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
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Studies of the drug tested here: Enzalutamide