3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01751451
• Collaborator: Janssen Scientific Affairs, LLC (Industry), OHSU Knight Cancer Institute (Other), Rutgers Cancer Institute of New Jersey (Other), NorthShore University HealthSystem (Other), Duke University (Other), Feinberg School of Medicine, 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)
• Enrollment: 124
• Locations: 16
• Arms: 3
• Actual Duration (Months): 93.3
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Abiraterone acetate; Drug: Abiraterone acetate plus degarelix; Drug: Degarelix	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
• Actual Study Start Date: Dec 18, 2012
• Actual Primary Completion Date: Sep 28, 2020
• Actual Study Completion Date: Sep 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone acetate Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months	Drug: 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.
Experimental: Abiraterone acetate and Degarelix Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month x 8 months	Drug: 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.
Experimental: Degarelix Group 3 • Degarelix subcutaneous depot injection q 1 month x 8 months	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) [18 months]

   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).

2. Soft Tissue Complete Response [1 year]

   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.

Secondary Outcome Measures

1. PSA Response Rate [8 months]

   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.

2. Overall Quality of Life [1 year]

   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,

3. Non-hematologic Adverse Events [1 year]

   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.

4. Testosterone and Luteinizing Hormone (LH) Recovery Rates [8 -10 months]

   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.

5. Correlative Tissue Analysis [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.

• Male aged 18 years and above

• Patients must have undergone local treatment via radical prostatectomy

• Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.

• Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible

• Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:

• Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND

• PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR

• Rising PSA as defined above AND

• Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes < 2 cm in short axis.

• Patients must have a serum testosterone of 150 ng/dL or greater

• ECOG performance status of ≤ 2 (Appendix A)

• Adequate bone marrow, hepatic, and renal function, as evidenced within 14 days prior to treatment initiation by:

• Absolute neutrophil count (ANC) ≥ 1500/mm3

• Platelet count ≥ 100,000/mm3

• Hemoglobin ≥ 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation

• Aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of the normal range (x ULN)

• Alanine aminotransferase (ALT) ≤ 1.5 x ULN

• Total bilirubin ≤ 1.5 x ULN

• Serum creatinine of ≤ 1.5 mg/dl or Calculated creatinine clearance of ≥ 60 mL/min

• Serum albumin ≥ 3.0 g/dL

• Serum potassium ≥ 3.5 mEq/L

• Prothrombin time (PT) ≤ 1.5 x ULN (or international normalized ratio [INR] ≤ 1.3) unless the patient is receiving anticoagulant therapy

• Partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy At least 4 weeks and recovery to Grade 0-1 from reversible effects of prior surgery (i.e., incisional pain, wound drainage)

• Able to swallow the study drug whole as a tablet

• Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken

• Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate.

Exclusion Criteria:

• Prior cytotoxic chemotherapy or biologic therapy for prostate cancer

• More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex) Note: Patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol.

• Prior ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer.

• Known brain metastasis or evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration

• Patients with equivocal uptake on a bone scan that in the clinician's opinion do not definitively constitute metastatic disease are eligible

• Currently active second malignancy

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:

• Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

• Severe hepatic impairment (Child-Pugh Class C)

• History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents

• Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment

• Active or symptomatic viral hepatitis or chronic liver disease

• History of pituitary or adrenal dysfunction

• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline

• Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy

• Uncontrolled diabetes mellitus

• Active psychiatric condition Use of any prohibited concomitant medications (Section 5.5) within 30 days prior to Cycle 1, Day 1

• Pre-existing condition that warrants long-term corticosteroid use in excess of study dose

• Grade > 2 treatment-related toxicity from prior therapy

• Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone or degarelix

• Administration of an investigational therapeutic within 30 days of Cycle 1, Day1

• Any condition which, in the opinion of the investigator, would preclude participation in this trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University, Feinberg School of Medicine	Chicago	Illinois	United States	60611
2	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21287
3	Karmanos Cancer Institute, Wayne State University	Detroit	Michigan	United States	48201
4	Urology Cancer Center and GU Research Network	Omaha	Nebraska	United States	68130
5	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey	United States
6	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
7	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York	United States	11725
8	Memorial Sloan Kettering West Harrison	Harrison	New York	United States	10604
9	NorthShore University Health System	Long Island City	New York	United States
10	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
11	Weill Cornell Medical Center	New York	New York	United States
12	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York	United States
13	Memoral Sloan Kettering Cancer Center at Phelps	Sleepy Hollow	New York	United States	10591
14	University of North Carolina	Chapel Hill	North Carolina	United States	27514
15	Duke University Medical Center	Durham	North Carolina	United States	27701
16	Oregon Health & Science University Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• Janssen Scientific Affairs, LLC
• OHSU Knight Cancer Institute
• Rutgers Cancer Institute of New Jersey
• NorthShore University HealthSystem
• Duke University
• Feinberg School of Medicine, Northwestern University
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• University of North Carolina
• Wayne State University
• Perlmutter New York University Cancer Center
• Weill Medical College of Cornell University
• Ferring Pharmaceuticals
• GU Research Network, LLC
• University of California, Los Angeles

Investigators

• Principal Investigator: Howard I Scher, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2017

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01751451
• Other Study ID Numbers: 12-187
• First Posted: Dec 18, 2012
• Last Update Posted: Nov 19, 2021
• Last Verified: Sep 1, 2020

• Keywords provided by Memorial Sloan Kettering Cancer Center: ABIRATERONE ACETATE (CB 7630); DEGARELIX; PREDNISONE; 12-187
• Additional relevant MeSH terms: Prostatic Neoplasms; Abiraterone Acetate

Study Results

Participant Flow

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Period Title: Overall Study
STARTED	42	40	42
COMPLETED	42	40	42
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix	Total
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.	Total of all reporting groups
Overall Participants	42	40	42	124
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.6	66.2	63.7	64.5
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	42 100%	40 100%	42 100%	124 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	1 2.4%	1 0.8%
Not Hispanic or Latino	42 100%	40 100%	41 97.6%	123 99.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	4 9.5%	4 10%	3 7.1%	11 8.9%
White	37 88.1%	31 77.5%	38 90.5%	106 85.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.4%	5 12.5%	1 2.4%	7 5.6%
Region of Enrollment (Count of Participants)
United States	42 100%	40 100%	42 100%	124 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS)
Description	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).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	42	40	42
Mean (95% Confidence Interval) [percentage change of PSA]	5.1	17.1	11.9

2. Primary Outcome

Title	Soft Tissue Complete Response
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

3. Secondary Outcome

Title	PSA Response Rate
Description	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.
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

4. Secondary Outcome

Title	Overall Quality of Life
Description	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,
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Non-hematologic Adverse Events
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Testosterone and Luteinizing Hormone (LH) Recovery Rates
Description	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.
Time Frame	8 -10 months

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

7. Secondary Outcome

Title	Correlative Tissue Analysis
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

N/A - data were not collected

Arm/Group Title	Abiraterone Acetate	Abiraterone Acetate and Degarelix	Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.	Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.	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.
Measure Participants	0	0	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Abiraterone Acetate		Abiraterone Acetate and Degarelix		Degarelix
Arm/Group Description	Group 1 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months 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.		Group 2 Abiraterone acetate 1000 mg daily x 8 months Prednisone 5 mg once daily x 8 months Degarelix subcutaneous depot injection q 1 month 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.		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.
All Cause Mortality
	Abiraterone Acetate		Abiraterone Acetate and Degarelix		Degarelix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)		3/40 (7.5%)		0/42 (0%)
Serious Adverse Events
	Abiraterone Acetate		Abiraterone Acetate and Degarelix		Degarelix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)		5/40 (12.5%)		4/42 (9.5%)
Cardiac disorders
Aortic valve disease	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Endocrine disorders
Adrenal insufficiency	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
General disorders
Fever	2/42 (4.8%)		0/40 (0%)		0/42 (0%)
Infections and infestations
Appendicitis	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Pelvic infection	1/42 (2.4%)		0/40 (0%)		0/42 (0%)
Sepsis	1/42 (2.4%)		0/40 (0%)		0/42 (0%)
Urinary tract infection	1/42 (2.4%)		0/40 (0%)		1/42 (2.4%)
Injury, poisoning and procedural complications
Fall	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Metabolism and nutrition disorders
Dehydration	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Hyperglycemia	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Pain	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Nervous system disorders
Stroke	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Syncope	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Psychiatric disorders
Psychiatric disorders - Other, specify	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Renal and urinary disorders
Hematuria	1/42 (2.4%)		0/40 (0%)		0/42 (0%)
Renal and urinary disorders - Other, specify	0/42 (0%)		0/40 (0%)		1/42 (2.4%)
Urinary tract obstruction	1/42 (2.4%)		0/40 (0%)		0/42 (0%)
Urinary tract pain	1/42 (2.4%)		0/40 (0%)		1/42 (2.4%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/42 (0%)		1/40 (2.5%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Abiraterone Acetate		Abiraterone Acetate and Degarelix		Degarelix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/42 (11.9%)		5/40 (12.5%)		4/42 (9.5%)
Blood and lymphatic system disorders
Anemia	2/42 (4.8%)		0/40 (0%)		0/42 (0%)
Investigations
Alanine aminotransferase increased	1/42 (2.4%)		3/40 (7.5%)		0/42 (0%)
Blood bilirubin increased	2/42 (4.8%)		2/40 (5%)		0/42 (0%)
Lymphocyte count decreased	1/42 (2.4%)		0/40 (0%)		3/42 (7.1%)
Metabolism and nutrition disorders
Hyperglycemia	5/42 (11.9%)		2/40 (5%)		3/42 (7.1%)
Hypocalcemia	2/42 (4.8%)		0/40 (0%)		1/42 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.