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)
124
Enrollment
16
Locations
3
Arms
93.3
Actual Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Northwestern University, Feinberg School of MedicineChicagoIllinoisUnited States60611
2Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMarylandUnited States21287
3Karmanos Cancer Institute, Wayne State UniversityDetroitMichiganUnited States48201
4Urology Cancer Center and GU Research NetworkOmahaNebraskaUnited States68130
5Memoral Sloan Kettering Cancer CenterBasking RidgeNew JerseyUnited States
6Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States08903
7Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew YorkUnited States11725
8Memorial Sloan Kettering West HarrisonHarrisonNew YorkUnited States10604
9NorthShore University Health SystemLong Island CityNew YorkUnited States
10Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
11Weill Cornell Medical CenterNew YorkNew YorkUnited States
12Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew YorkUnited States
13Memoral Sloan Kettering Cancer Center at PhelpsSleepy HollowNew YorkUnited States10591
14University of North CarolinaChapel HillNorth CarolinaUnited States27514
15Duke University Medical CenterDurhamNorth CarolinaUnited States27701
16Oregon Health & Science University Knight Cancer InstitutePortlandOregonUnited States97239

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)

More Information

Additional Information:

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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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
STARTED424042
COMPLETED424042
NOT COMPLETED000

Baseline Characteristics

Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelixTotal
Arm/Group DescriptionGroup 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 Participants424042124
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
TitleProgression-free Survival (PFS)
Descriptiondefined 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 Frame18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants424042
Mean (95% Confidence Interval) [percentage change of PSA]
5.1
17.1
11.9
2. Primary Outcome
TitleSoft Tissue Complete Response
DescriptionIn 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 Frame1 year

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000
3. Secondary Outcome
TitlePSA Response Rate
DescriptionThe 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 Frame8 months

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000
4. Secondary Outcome
TitleOverall Quality of Life
Descriptionwith 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 Frame1 year

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000
5. Secondary Outcome
TitleNon-hematologic Adverse Events
DescriptionSafety 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 Frame1 year

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000
6. Secondary Outcome
TitleTestosterone and Luteinizing Hormone (LH) Recovery Rates
DescriptionTestosterone 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 Frame8 -10 months

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000
7. Secondary Outcome
TitleCorrelative Tissue Analysis
DescriptionTissue 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 Frame1 year

Outcome Measure Data

Analysis Population Description
N/A - data were not collected
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 Participants000

Adverse Events

Time Frame1 year
Adverse Event Reporting Description
Arm/Group TitleAbiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Arm/Group DescriptionGroup 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 AcetateAbiraterone Acetate and DegarelixDegarelix
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/42 (4.8%) 3/40 (7.5%) 0/42 (0%)
Serious Adverse Events
Abiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/42 (4.8%) 5/40 (12.5%) 4/42 (9.5%)
Cardiac disorders
Aortic valve disease0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Endocrine disorders
Adrenal insufficiency0/42 (0%) 0/40 (0%) 1/42 (2.4%)
General disorders
Fever2/42 (4.8%) 0/40 (0%) 0/42 (0%)
Infections and infestations
Appendicitis0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Pelvic infection1/42 (2.4%) 0/40 (0%) 0/42 (0%)
Sepsis1/42 (2.4%) 0/40 (0%) 0/42 (0%)
Urinary tract infection1/42 (2.4%) 0/40 (0%) 1/42 (2.4%)
Injury, poisoning and procedural complications
Fall0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Metabolism and nutrition disorders
Dehydration0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Hyperglycemia0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Musculoskeletal and connective tissue disorders
Arthritis0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Pain0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Nervous system disorders
Stroke0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Syncope0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Psychiatric disorders
Psychiatric disorders - Other, specify0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Renal and urinary disorders
Hematuria1/42 (2.4%) 0/40 (0%) 0/42 (0%)
Renal and urinary disorders - Other, specify0/42 (0%) 0/40 (0%) 1/42 (2.4%)
Urinary tract obstruction1/42 (2.4%) 0/40 (0%) 0/42 (0%)
Urinary tract pain1/42 (2.4%) 0/40 (0%) 1/42 (2.4%)
Respiratory, thoracic and mediastinal disorders
Dyspnea0/42 (0%) 1/40 (2.5%) 0/42 (0%)
Other (Not Including Serious) Adverse Events
Abiraterone AcetateAbiraterone Acetate and DegarelixDegarelix
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/42 (11.9%) 5/40 (12.5%) 4/42 (9.5%)
Blood and lymphatic system disorders
Anemia2/42 (4.8%) 0/40 (0%) 0/42 (0%)
Investigations
Alanine aminotransferase increased1/42 (2.4%) 3/40 (7.5%) 0/42 (0%)
Blood bilirubin increased2/42 (4.8%) 2/40 (5%) 0/42 (0%)
Lymphocyte count decreased1/42 (2.4%) 0/40 (0%) 3/42 (7.1%)
Metabolism and nutrition disorders
Hyperglycemia5/42 (11.9%) 2/40 (5%) 3/42 (7.1%)
Hypocalcemia2/42 (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.

Results Point of Contact

Name/TitleDr. Howard Scher, MD
OrganizationMemorial Sloan Kettering Cancer Center
Phone646-888-4878
Emailscherh@MSKCC.ORG
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