Metastatic Castration Resistant Prostate Cancer
Conditions
Keywords
Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Enzalutamide, Xtandi, MDV3100
Brief summary
The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).
Interventions
DRUGEnzalutamide
Enzalutamide was administered orally
DRUGAndrogen deprivation therapy (ADT)
All participants were required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. * Subject with established diagnosis of metastatic castration-resistant prostate carcinoma. * Subject is being newly initiated on Xtandi treatment (Enzalutamide). * Subject has an estimated life expectancy of ≥ 6 months. * Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
* Subject who is not eligible to receive Xtandi as per the locally approved prescribing information. * Subject participating or planning to participate in any interventional drug trial during the course of this trial. * Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening. * Subject has any condition which makes the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment- Emergent Adverse Events (TEAEs) | From first dose of study drug until 30 days after last dose (Up to 1899 days) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response | Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899) | Confirmed PSA response rate was defined as the percentage of participants with \>= 50% decline in PSA from baseline to the lowest postbaseline PSA result, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. |
Countries
India
Contacts
STUDY_DIRECTORCentral Contact
Astellas Pharma Inc
Participant flow
Recruitment details
Indian male participants with progressive mCRPC previously treated with docetaxel-based chemotherapy were enrolled in this study.
Pre-assignment details
Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Enzalutamide Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Enzalutamide |
|---|---|
| Age, Continuous | 66.5 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 52 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 52 |
| other Total, other adverse events | 25 / 52 |
| serious Total, serious adverse events | 10 / 52 |
Outcome results
Primary
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
Time frame: From first dose of study drug until 30 days after last dose (Up to 1899 days)
Population: SAF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enzalutamide | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) | 36 Participants |
Secondary
Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response
Confirmed PSA response rate was defined as the percentage of participants with \>= 50% decline in PSA from baseline to the lowest postbaseline PSA result, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response.
Time frame: Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899)
Population: Full Analysis Set (FAS): The FAS consisted of all participants who received at least one dose of study drug and had at least one post baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enzalutamide | Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response | 46 Percentage of Participants |