Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
1 other identifier
interventional
69
1 country
21
Brief Summary
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2011
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
June 12, 2017
CompletedMarch 19, 2019
March 1, 2019
4.4 years
December 6, 2011
March 27, 2017
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative CD54 Upregulation Ratio Between the Cohorts.
An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
Over the course of sipuleucel-T therapy (approximately 1 month)
Study Arms (2)
Concurrent Arm
EXPERIMENTALSubjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.
Sequential Arm
EXPERIMENTALSubjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.
Interventions
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
Eligibility Criteria
You may qualify if:
- histologically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
- metastatic status as evidenced by imaging obtained \</= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
- castrate resistant prostate cancer: castrate levels of testosterone (\</= 50 ng/dL); evidence of disease progression concomitant with surgical or medical castration
- serum PSA \>/= 2.0 ng/mL
- castrate levels of testosterone (\</= 50 ng/dL) achieved via medical or surgical castration
- baseline Eastern Cooperative Oncology Group (ECOG) performance status of \</= 1
- systolic blood pressure (BP) \</= 140 mm Hg and diastolic BP \</= 90 mm Hg at screening
- adequate baseline hematologic, renal, and liver functions
- must live in a permanent residence within a comfortable driving distance (round trip within one day) of the clinical trial site
You may not qualify if:
- the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
- New York Heart Association Class III or IV heart failure
- any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
- Child-Pugh Class B or C hepatic insufficiency
- spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
- known adrenalcortical insufficiency
- any medical contraindications to receiving prednisone
- prior treatment with sipuleucel-T
- previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))
- a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled, intra-nasal, intra-articular, and topical steroids was allowed.
- treatment with any investigational vaccine or immunotherapy
- treatment with any chemotherapy prior to registration.
- a history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
- myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to registration
- ongoing anti-androgen withdrawal response.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (21)
UCSD Medical Center - La Jolla
La Jolla, California, 92037, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
UCSD Medical Center - Hillcrest
San Diego, California, 92103, United States
Medical Oncology Associates - SD
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Georgetown University Medical Center - Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Mid Atlantic Urology Associates, Mid Atlantic Clinical Research
Greenbelt, Maryland, 20770, United States
GU Research Center, LLC
Omaha, Nebraska, 68130, United States
NYU Clinical Cancer Center, NYU Langone Medical Center
New York, New York, 10016, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Associated Medical Professionals of NY, PLLC
Oneida, New York, 13421, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210, United States
Providence Cancer Center Oncology and Hematology Care
Portland, Oregon, 97213, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (1)
Antonarakis ES, Subudhi SK, Pieczonka CM, Karsh LI, Quinn DI, Hafron JM, Wilfehrt HM, Harmon M, Sheikh NA, Shore ND, Petrylak DP. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clin Cancer Res. 2023 Jul 5;29(13):2426-2434. doi: 10.1158/1078-0432.CCR-22-3832.
PMID: 37058234DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shabnam Vaziri
- Organization
- Dendreon
Study Officials
- STUDY DIRECTOR
Robert Israel, MD
Valeant Pharmaceuticals North America LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
December 1, 2011
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
March 19, 2019
Results First Posted
June 12, 2017
Record last verified: 2019-03