Intermediate Risk Prostate Cancer
Conditions
Keywords
Intermediate Risk Prostate Cancer
Brief summary
This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream.
Detailed description
* The participant will be given a study drug-dosing diary for each of 6 treatment cycles. Each treatment cycle lasts 28 days (4 weeks), during which time the participant will be taking the study drug enzalutamide by mouth (4 pills daily). The diary will also include special instructions for taking the enzalutamide. * The participant will also be undergoing external beam radiation therapy during the study, for a duration of 8 ½-10 weeks. Treatment will be administered on an outpatient basis. This part of the study is considered standard of care. * The participant will be required to have fiducial markers placed within the prostate as part of this study. These are very small gold markers that are placed in the prostate. This procedure is similar to the biopsy that the participant had to diagnose their cancer. This procedure is routinely performed to permit imaging and position corrections to improve the precision of the external beam (radiation) delivery (Image Guided Radiation Therapy). The placement of the three gold markers is performed by an Urologist. The fiducials are placed under ultrasound guidance. This is also considered standard of care and is not experimental. * Planned Follow-up: Participants will be followed on study at a 3 month follow-up after treatment (cessation of enzalutamide). Additional follow-up to assess the status of the participant's cancer will be conducted at the discretion of the treating physicians as part of the participant's routine medical care.
Interventions
DRUGEnzalutamide
RADIATIONExternal Beam Radiation
Sponsors
Medivation, Inc.
Dana-Farber Cancer Institute
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
* Study population: Participants must have histologically confirmed malignancy and are candidates for external beam radiation therapy. Patients eligible for this study must have intermediate risk disease defined as PSA values between 10-20 ng/ml and/or T2b-c and/or Gleason grade 7. If all three are present, less than 50% of the core biopsies can be positive. * Patients previously diagnosed with low risk (Gleason score \< 6, clinical stage \< T2a, and PSA\< 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure. * Age 18 years or more. * Life expectancy of greater than 1 year. * ECOG performance status ≤ 2 (see Appendix D). * Participants must have normal organ and marrow function as defined below: * Leukocytes ≥3,000/mcL * Platelets ≥80,000/mcL * Total bilirubin \< 2X institutional upper limit * AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal * Creatinine \< 2x institutional limits . * The effects of enzalutamide on the developing human fetus are unknown. For this reason and because enzalutamide may be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Ability to understand and the willingness to sign a written informed consent
Exclusion criteria
* Patients must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With PSA at or Below 0.2 ng/ml | End of treatment, up to 27 weeks. | Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Androstenedione | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median androstenedione, collected and assessed using established methods. Reference range is 40-150 ng/dL for adult males. |
| Median Testosterone | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median testosterone, collected and assessed using established methods. Reference range is 300-1050 ng/dL for adult males. |
| Median Free Testosterone | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median free testosterone, collected and assessed using established methods. Reference range is 350-1200 ng/dL for adult males. |
| Median Estrone | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median estrone, collected and assessed using established methods. Reference range is 12-72 pg/mL for adult males. |
| Median Estradiol | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median estradiol, collected and assessed using established methods. The reference range is 13-42 pg/mL for adult males. |
| Median Bicep Fat Fold Measurement | At baseline and end of treatment, up to 27 weeks | Median bicep fat fold measurement taken at baseline and end of treatment. |
| Median Tricep Fat Fold Measurement | At baseline and end of treatment, up to 27 weeks | Median tricep fat fold measurement taken at baseline and end of treatment. |
| Median Shoulder Blade Fat Fold Measurement | At baseline and end of treatment, up to 27 weeks | Median shoulder blade fat fold measurement taken at baseline and end of treatment. |
| Median Waist Fat Fold Measurement | At baseline and end of treatment, up to 27 weeks | Median waist fat fold measurement taken at baseline and end of treatment. |
| Median Waist Circumference | At baseline and end of treatment, up to 27 weeks | Median waist circumference taken at baseline and end of treatment. |
| Median DHEA-S | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks | Median DHEA-S, collected and assessed using established methods. Reference range is 28-640 ug/dL for adult males. |
| Number of Participants With a Sleep Quality Score of 0 or 1 | Measured at cycles 1, 3, and 5. | Sleep quality measure of the Pittsburgh Sleep Quality Index (PSQI) is scored from 0-3 \[0=Very bad, 1=Fairly bad, 2=Fairly good, 3=Very good\]. The higher the score, the better the sleep quality. |
| Urinary Incontinence Median Score | Measured at cycles 1, 3, and 5. | Urinary incontinence evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26) EPIC-26 evaluates patient's urinary incontinence (4 items). The 4 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. |
| Urinary Irritation Median Score | Measured at cycles 1, 3, and 5. | Urinary irritation evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates urinary irritation/obstruction (4 items). The final score from the 4 items is reported on a scale of 0 - 100. A higher score indicates better urinary function. |
| Bowel Function Median Score | Measured at cycles 1, 3, and 5. | Bowel function measure through the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's bowel (6 items). The 6 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. |
| Sexual Function Median Score | Measured at cycles 1, 3, and 5. | Sexual function measure through The Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's sexual function (5 items). The 5 items are reported on a scale of 0 - 100.A higher score indicates better urinary function. |
| Hormone Function Median Score | Measured at cycles 1, 3, and 5. | Hormone function evaluated by the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's hormonal function (5 items). The 5 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. |
| Number of Participants With a Fatigue Score of 3 or 4 | Cycles 1, 3, and 5 | Feeling fatigue measure of the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue Short Form is scored from 0-4 \[0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much\]. The higher the score, the more fatigued the patient is. |
| Median Collagen Type 1 C-Telopeptide | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks | Median Collagen Type 1 C-Telopeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 60-1200 pg/mL |
| Median Bone-Specific Alkaline Phosphatase | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks | Median Bone-Specific Alkaline Phosphatase is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 7.5-69.8 ug/L |
| Median Procollagen Type II Intact N Terminal Propeptide | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks | Median Procollagen Type II Intact N Terminal Propeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 22-87 ug/L |
| Median Weight | At baseline and end of treatment, up to 27 weeks | Median weight taken at baseline and end of treatment. |
Countries
United States
Participant flow
Recruitment details
Enrollment from February 2014 to February 2017
Participants by arm
| Arm | Count |
|---|---|
| Enzalutamide With External Beam Radiation Enzalutamide
40 mg orally 4x daily for 6 (28 day +/-3 days) cycles.
External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide
75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks.
\*Patients that are unable to complete enzalutamide therapy will still be treated with EBRT
Enzalutamide
External Beam Radiation | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Enzalutamide With External Beam Radiation |
|---|---|
| Age, Continuous | 70 years |
| Baseline Prostate Specific Antigen (PSA) | 7.72 ng/mL |
| Gleason Score 6 | 2 Participants |
| Gleason Score 7 | 62 Participants |
| M Stage M0 | 50 Participants |
| M Stage M1 | 0 Participants |
| M Stage MX | 9 Participants |
| M Stage Unknown | 5 Participants |
| N Stage N0 | 50 Participants |
| N Stage N1 | 0 Participants |
| N Stage NX | 12 Participants |
| N Stage Unknown | 2 Participants |
| Primary Gleason Score 3 | 38 Participants |
| Primary Gleason Score 4 | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Risk Stratification Favorable | 10 Participants |
| Risk Stratification Unfavorable | 54 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 64 Participants |
| T Stage T1a | 0 Participants |
| T Stage T1b | 0 Participants |
| T Stage T1c | 43 Participants |
| T Stage T2a | 18 Participants |
| T Stage T2b | 1 Participants |
| T Stage T2c | 2 Participants |
| T Stage T3 | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 64 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
Percentage of Participants With PSA at or Below 0.2 ng/ml
Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis).
Time frame: End of treatment, up to 27 weeks.
Population: Participants who completed treatment are included in this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Percentage of Participants With PSA at or Below 0.2 ng/ml | <=0.2 ng/ml | 79 percentage of participants |
| Enzalutamide With External Beam Radiation | Percentage of Participants With PSA at or Below 0.2 ng/ml | >0.2 ng/ml | 21 percentage of participants |
Secondary
Bowel Function Median Score
Bowel function measure through the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's bowel (6 items). The 6 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Bowel Function Median Score | Cycle 1 | 100 score |
| Enzalutamide With External Beam Radiation | Bowel Function Median Score | Cycle 3 | 97.92 score |
| Enzalutamide With External Beam Radiation | Bowel Function Median Score | Cycle 5 | 89.58 score |
Secondary
Hormone Function Median Score
Hormone function evaluated by the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's hormonal function (5 items). The 5 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Hormone Function Median Score | Cycle 1 | 97.50 score |
| Enzalutamide With External Beam Radiation | Hormone Function Median Score | Cycle 3 | 90 score |
| Enzalutamide With External Beam Radiation | Hormone Function Median Score | Cycle 5 | 75 score |
Secondary
Median Androstenedione
Median androstenedione, collected and assessed using established methods. Reference range is 40-150 ng/dL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Androstenedione | Cycle 1 | 56.5 ng/dL |
| Enzalutamide With External Beam Radiation | Median Androstenedione | Cycle 5 | 77.5 ng/dL |
| Enzalutamide With External Beam Radiation | Median Androstenedione | End of treatment | 76.5 ng/dL |
Secondary
Median Bicep Fat Fold Measurement
Median bicep fat fold measurement taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Bicep Fat Fold Measurement | Baseline | 14 mm |
| Enzalutamide With External Beam Radiation | Median Bicep Fat Fold Measurement | End of treatment | 18 mm |
Secondary
Median Bone-Specific Alkaline Phosphatase
Median Bone-Specific Alkaline Phosphatase is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 7.5-69.8 ug/L
Time frame: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Bone-Specific Alkaline Phosphatase | Baseline | 11.5 ug/L |
| Enzalutamide With External Beam Radiation | Median Bone-Specific Alkaline Phosphatase | Off-Treatment | 12 ug/L |
| Enzalutamide With External Beam Radiation | Median Bone-Specific Alkaline Phosphatase | 3 Month Follow-up | 12.6 ug/L |
Secondary
Median Collagen Type 1 C-Telopeptide
Median Collagen Type 1 C-Telopeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 60-1200 pg/mL
Time frame: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Collagen Type 1 C-Telopeptide | Baseline | 295.5 pg/mL |
| Enzalutamide With External Beam Radiation | Median Collagen Type 1 C-Telopeptide | Off-Treatment | 397 pg/mL |
| Enzalutamide With External Beam Radiation | Median Collagen Type 1 C-Telopeptide | 3 Month Follow-up | 314 pg/mL |
Secondary
Median DHEA-S
Median DHEA-S, collected and assessed using established methods. Reference range is 28-640 ug/dL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median DHEA-S | Cycle 1 | 98 ug/dL |
| Enzalutamide With External Beam Radiation | Median DHEA-S | Cycle 5 | 141 ug/dL |
| Enzalutamide With External Beam Radiation | Median DHEA-S | End of treatment | 135 ug/dL |
Secondary
Median Estradiol
Median estradiol, collected and assessed using established methods. The reference range is 13-42 pg/mL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Estradiol | Cycle 1 | 22.5 pg/mL |
| Enzalutamide With External Beam Radiation | Median Estradiol | Cycle 5 | 45 pg/mL |
| Enzalutamide With External Beam Radiation | Median Estradiol | End of treatment | 45 pg/mL |
Secondary
Median Estrone
Median estrone, collected and assessed using established methods. Reference range is 12-72 pg/mL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Estrone | Cycle 1 | 37 pg/mL |
| Enzalutamide With External Beam Radiation | Median Estrone | Cycle 5 | 40 pg/mL |
| Enzalutamide With External Beam Radiation | Median Estrone | End of treatment | 39 pg/mL |
Secondary
Median Free Testosterone
Median free testosterone, collected and assessed using established methods. Reference range is 350-1200 ng/dL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Free Testosterone | Cycle 1 | 66 pg/mL |
| Enzalutamide With External Beam Radiation | Median Free Testosterone | Cycle 5 | 100 pg/mL |
| Enzalutamide With External Beam Radiation | Median Free Testosterone | End of treatment | 86 pg/mL |
Secondary
Median Procollagen Type II Intact N Terminal Propeptide
Median Procollagen Type II Intact N Terminal Propeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 22-87 ug/L
Time frame: Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Procollagen Type II Intact N Terminal Propeptide | Baseline | 12.8 ug/L |
| Enzalutamide With External Beam Radiation | Median Procollagen Type II Intact N Terminal Propeptide | Off-Treatment | 13.5 ug/L |
| Enzalutamide With External Beam Radiation | Median Procollagen Type II Intact N Terminal Propeptide | 3 Month Follow-up | 13.4 ug/L |
Secondary
Median Shoulder Blade Fat Fold Measurement
Median shoulder blade fat fold measurement taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Shoulder Blade Fat Fold Measurement | Baseline | 20 mm |
| Enzalutamide With External Beam Radiation | Median Shoulder Blade Fat Fold Measurement | End of treatment | 22 mm |
Secondary
Median Testosterone
Median testosterone, collected and assessed using established methods. Reference range is 300-1050 ng/dL for adult males.
Time frame: Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Testosterone | Cycle 1 | 349.5 ng/dL |
| Enzalutamide With External Beam Radiation | Median Testosterone | Cycle 5 | 760 ng/dL |
| Enzalutamide With External Beam Radiation | Median Testosterone | End of treatment | 730.5 ng/dL |
Secondary
Median Tricep Fat Fold Measurement
Median tricep fat fold measurement taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Tricep Fat Fold Measurement | Baseline | 20 mm |
| Enzalutamide With External Beam Radiation | Median Tricep Fat Fold Measurement | End of treatment | 24 mm |
Secondary
Median Waist Circumference
Median waist circumference taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Waist Circumference | Baseline | 104.6 mm |
| Enzalutamide With External Beam Radiation | Median Waist Circumference | End of treatment | 104.6 mm |
Secondary
Median Waist Fat Fold Measurement
Median waist fat fold measurement taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Waist Fat Fold Measurement | Baseline | 28 mm |
| Enzalutamide With External Beam Radiation | Median Waist Fat Fold Measurement | End of treatment | 28 mm |
Secondary
Median Weight
Median weight taken at baseline and end of treatment.
Time frame: At baseline and end of treatment, up to 27 weeks
Population: The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Median Weight | Baseline | 87.35 kg |
| Enzalutamide With External Beam Radiation | Median Weight | End of treatment | 88.26 kg |
Secondary
Number of Participants With a Fatigue Score of 3 or 4
Feeling fatigue measure of the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue Short Form is scored from 0-4 \[0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much\]. The higher the score, the more fatigued the patient is.
Time frame: Cycles 1, 3, and 5
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Number of Participants With a Fatigue Score of 3 or 4 | Cycle 1 | 2 Participants |
| Enzalutamide With External Beam Radiation | Number of Participants With a Fatigue Score of 3 or 4 | Cycle 3 | 13 Participants |
| Enzalutamide With External Beam Radiation | Number of Participants With a Fatigue Score of 3 or 4 | Cycle 5 | 13 Participants |
Secondary
Number of Participants With a Sleep Quality Score of 0 or 1
Sleep quality measure of the Pittsburgh Sleep Quality Index (PSQI) is scored from 0-3 \[0=Very bad, 1=Fairly bad, 2=Fairly good, 3=Very good\]. The higher the score, the better the sleep quality.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Number of Participants With a Sleep Quality Score of 0 or 1 | Cycle 1 | 54 Participants |
| Enzalutamide With External Beam Radiation | Number of Participants With a Sleep Quality Score of 0 or 1 | Cycle 3 | 43 Participants |
| Enzalutamide With External Beam Radiation | Number of Participants With a Sleep Quality Score of 0 or 1 | Cycle 5 | 45 Participants |
Secondary
Sexual Function Median Score
Sexual function measure through The Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's sexual function (5 items). The 5 items are reported on a scale of 0 - 100.A higher score indicates better urinary function.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Sexual Function Median Score | Cycle 1 | 62.5 score |
| Enzalutamide With External Beam Radiation | Sexual Function Median Score | Cycle 3 | 32 score |
| Enzalutamide With External Beam Radiation | Sexual Function Median Score | Cycle 5 | 19.42 score |
Secondary
Urinary Incontinence Median Score
Urinary incontinence evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26) EPIC-26 evaluates patient's urinary incontinence (4 items). The 4 items are reported on a scale of 0 - 100. A higher score indicates better urinary function.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Urinary Incontinence Median Score | Cycle 1 | 100 score |
| Enzalutamide With External Beam Radiation | Urinary Incontinence Median Score | Cycle 3 | 100 score |
| Enzalutamide With External Beam Radiation | Urinary Incontinence Median Score | Cycle 5 | 84.38 score |
Secondary
Urinary Irritation Median Score
Urinary irritation evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates urinary irritation/obstruction (4 items). The final score from the 4 items is reported on a scale of 0 - 100. A higher score indicates better urinary function.
Time frame: Measured at cycles 1, 3, and 5.
Population: The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enzalutamide With External Beam Radiation | Urinary Irritation Median Score | Cycle 1 | 87.50 score |
| Enzalutamide With External Beam Radiation | Urinary Irritation Median Score | Cycle 3 | 81.25 score |
| Enzalutamide With External Beam Radiation | Urinary Irritation Median Score | Cycle 5 | 62.5 score |