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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide, Leuprolide, radiation | Other | Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | 160mg by mouth each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation | Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0 | 12 months following initiation of treatment with enzalutamide plus GnRH agonist |
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy | Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Courtney, MD, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28191869 | Background | Li J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183. |
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7 met criteria and were enrolled in the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide, Leuprolide, Radiation | Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide: 160mg by mouth each day Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months radiation: External beam radiation will be delivered as per standard radiation therapy protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide, Leuprolide, Radiation | Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide: 160mg by mouth each day Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months radiation: External beam radiation will be delivered as per standard radiation therapy protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation | Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0 | Posted | Count of Participants | Participants | 12 months following initiation of treatment with enzalutamide plus GnRH agonist |
|
Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzalutamide, Leuprolide, Radiation | Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide: 160mg by mouth each day Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months radiation: External beam radiation will be delivered as per standard radiation therapy protocol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain / bloating | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Courtney, MD | UT Southwestern Medical Center | 214-648-4180 | Kevin.Courtney@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2016 | Aug 11, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2016 | Aug 11, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D016729 | Leuprolide |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Leuprolide acetate | Drug | 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months |
|
|
| radiation | Radiation | External beam radiation will be delivered as per standard radiation therapy protocol |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy | Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy. | Posted | Median | Full Range | Fold change | 12 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aneurysm internal iliac artery | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety / depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower extremity edema | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| hot flashes / night sweats | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea / loose stools | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone metastasis | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruit of left carotid artery | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cataract, both eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Change in mole on neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Clammy skin, oiliness, filminess skin/teeth | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lower back pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Color perception changes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Neuropathy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Decrease in energy | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Decreased night vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Emotional depression/insomina | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fall | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Folliculitis | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Frontal headaches | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Noctoria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| burning on urination | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hoarseness/ fullness in throat | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes with sweating/night sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vivid dreams | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increased hunger | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urethral pain/ dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary dribbling | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lightheadedness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower back pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Loss of smell | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone / joint pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Left pectoralis skin lesion bx squamous cell | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Transaminitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Morning Stiffness/ arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Internal tension | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory loss | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle pull left wrist | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Adenopathy | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic pain/prostate/ inguinal | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Poor appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Radiation proctitis | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
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| Rectal burning / irritation | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Recurrence of claudication in setting of PVD | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Right breast tenderness and swelling | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Short term memory impairment | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Ringing in ears | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seasonal Allergies | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spontaneous passage of kidney stone | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Stress Incontinence | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D055585 | Physical Phenomena |
| Title | Measurements |
|---|---|
|
| Fold change in NDRG1 |
|