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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
| OHSU Knight Cancer Institute | OTHER |
| Rutgers Cancer Institute of New Jersey | OTHER |
| Endeavor Health |
In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental | Group 1
|
|
| Abiraterone acetate and Degarelix | Experimental | Group 2 Abiraterone acetate 1000 mg daily x 8 months
|
|
| Degarelix | Experimental | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0). | 18 months |
| Soft Tissue Complete Response | In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response Rate | The percentage of patients with a non-castrate level of testosterone (>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured. | 8 months |
| Overall Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Howard I Scher, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone Acetate | Group 1
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 30, 2017 |
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| OTHER |
| Duke University | OTHER |
| Northwestern University | OTHER |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | OTHER |
| University of North Carolina | OTHER |
| Wayne State University | OTHER |
| Perlmutter New York University Cancer Center | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Ferring Pharmaceuticals | INDUSTRY |
| GU Research Network, LLC | OTHER |
| University of California, Los Angeles | OTHER |
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|
| Abiraterone acetate plus degarelix | Drug | Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. |
|
| Degarelix | Drug | Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life,
| 1 year |
| Non-hematologic Adverse Events | Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study. | 1 year |
| Testosterone and Luteinizing Hormone (LH) Recovery Rates | Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period. | 8 -10 months |
| Correlative Tissue Analysis | Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers. | 1 year |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Karmanos Cancer Institute, Wayne State University | Detroit | Michigan | 48201 | United States |
| Urology Cancer Center and GU Research Network | Omaha | Nebraska | 68130 | United States |
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering West Harrison | Harrison | New York | 10604 | United States |
| NorthShore University Health System | Long Island City | New York | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Medical Center | New York | New York | United States |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memoral Sloan Kettering Cancer Center at Phelps | Sleepy Hollow | New York | 10591 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| Oregon Health & Science University Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| FG001 | Abiraterone Acetate and Degarelix | Group 2 Abiraterone acetate 1000 mg daily x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. |
| FG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone Acetate | Group 1
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. |
| BG001 | Abiraterone Acetate and Degarelix | Group 2 Abiraterone acetate 1000 mg daily x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. |
| BG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| 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 |
|
| 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 | Progression-free Survival (PFS) | defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0). | Posted | Mean | 95% Confidence Interval | percentage change of PSA | 18 months |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Soft Tissue Complete Response | In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values. | N/A - data were not collected | Posted | 1 year |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PSA Response Rate | The percentage of patients with a non-castrate level of testosterone (>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured. | N/A - data were not collected | Posted | 8 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Quality of Life | with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life, | N/A - data were not collected | Posted | 1 year |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Non-hematologic Adverse Events | Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study. | N/A - data were not collected | Posted | 1 year |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Testosterone and Luteinizing Hormone (LH) Recovery Rates | Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period. | N/A - data were not collected | Posted | 8 -10 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Correlative Tissue Analysis | Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers. | N/A - data were not collected | Posted | 1 year |
|
1 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 | Abiraterone Acetate | Group 1
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food. | 2 | 42 | 2 | 42 | 5 | 42 |
| EG001 | Abiraterone Acetate and Degarelix | Group 2 Abiraterone acetate 1000 mg daily x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter. | 3 | 40 | 5 | 40 | 5 | 40 |
| EG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. | 0 | 42 | 4 | 42 | 4 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Aortic valve disease | Cardiac disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pelvic infection | Infections and infestations | Systematic Assessment |
| ||
| Psychiatric disorders - Other, specify | Psychiatric disorders | Systematic Assessment |
| ||
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Howard Scher, MD | Memorial Sloan Kettering Cancer Center | 646-888-4878 | scherh@MSKCC.ORG |
| Jun 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
| OG002 |
| Degarelix |
Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
| OG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
| OG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
| OG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|
| OG002 | Degarelix | Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter. |
|