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NCT02463799

Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC

Completed Phase 2 Results posted Last updated 8 July 2021
What this trial tests

Phase 2 trial testing Radium-223 in Prostate Cancer in 36 participants. Completed in 12 December 2019.

Timeline
22 February 2016
Primary endpoint
12 December 2019
12 December 2019

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment36
Start date22 February 2016
Primary completion12 December 2019
Estimated completion12 December 2019
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation Primary · 6 weeks

Peripheral PA2024-specific T-cell proliferation responses using a 3H-thymidine incorporation assay at 6 weeks after the first dose of sipuleucel-T, measured by SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ).

GroupValue95% CI
Sipuleucel-T and Radium 223 Combination7.04.12 – 20.2
Sipuleucel-T Alone22.417.2 – 31.4
Peripheral PA2024 Specific T-cell Proliferation as Measured by Stimulation Index Over Time Secondary · Up to 52 weeks

Mean peripheral PA2024 specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination1.71.0 – 2.2
Sipuleucel-T Alone1.41.2 – 1.5
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination25.74.4 – 37.0
Sipuleucel-T Alone49.830.5 – 44.5
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination27.88.6 – 34.2
Sipuleucel-T Alone42.026.3 – 56.0
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination23.07.0 – 21.8
Sipuleucel-T Alone42.232.1 – 56.1
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination27.212.2 – 26.4
Sipuleucel-T Alone25.615.4 – 36.6
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination20.75.4 – 22.3
Sipuleucel-T Alone25.325.3 – 25.3
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination16.54.4 – 23.3
Sipuleucel-T Alone11.811.8 – 11.8
Time to Radiographic or Clinical Progression Secondary · Up to 2 years

Number of weeks from baseline until radiographic or clinical progression, whichever comes first. Radiographic progression is assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and PCWG2 criteria (Prostate Cancer Working Group 2). Per RECIST, progression is defined as ≥ 20% and ≥ 5 mm from nadir of the sum of the diameters of target lesions. Per PCWG2 criteria, radiographic progression is defined as ≥ 20% sum of the longest diameter of target lesions, or ≥ 2 new lesions on bone scan from baseline. Clinical progression is defined as new spinal cord or nerve root compression, new p

GroupValue95% CI
Sipuleucel-T and Radium 223 Combination38.718.9 – NA
Sipuleucel-T Alone11.98.0 – 15.0
PSA50 Response (at Least a 50% Decline in PSA) Secondary · Up to 2 years

Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value

GroupValue95% CI
Sipuleucel-T and Radium 223 Combination0
Sipuleucel-T Alone5
Peripheral PAP Specific T-cell Proliferation as Measured by Stimulation Index Over Time Secondary · Up to 52 weeks

Mean peripheral PAP specific T-cell proliferation using a 3H-thymidine incorporation assay reported as SI (Stimulation Index \[3H-thymidine incorporation in the presence of antigen divided by 3H-thymidine incorporation with media alone\] ) at baseline and 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination1.10.7 – 1.0
Sipuleucel-T Alone1.21.0 – 1.4
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination1.60.9 – 1.4
Sipuleucel-T Alone12.51.3 – 4.6
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3.10.8 – 3.8
Sipuleucel-T Alone5.71.2 – 4.2
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination2.30.7 – 2.3
Sipuleucel-T Alone6.11.0 – 7.9
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3.90.7 – 3.8
Sipuleucel-T Alone1.51.0 – 1.7
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination4.11.3 – 3.5
Sipuleucel-T Alone1.81.8 – 1.8
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination2.20.5 – 3.1
Sipuleucel-T Alone1.91.9 – 1.9
Peripheral PA2024 Specific T-cell Activation Secondary · Up to 52 weeks

Mean peripheral PA2024 specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT), as measured by cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3.61.0 – 1.8
Sipuleucel-T Alone6.01.0 – 4.8
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination66.517.5 – 127.7
Sipuleucel-T Alone194.334.2 – 349.8
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination72.98.0 – 133.7
Sipuleucel-T Alone116.414.3 – 232.8
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination73.617.3 – 115.3
Sipuleucel-T Alone137.841.7 – 164.0
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination87.712.7 – 137.0
Sipuleucel-T Alone169.9112.7 – 247.8
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination27.36.4 – 43.8
Sipuleucel-T Alone19.019.0 – 19.0
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination22.412.0 – 33.2
Sipuleucel-T Alone26.026.0 – 26.0
Peripheral PAP Specific T-cell Activation Secondary · Up to 52 weeks

Mean peripheral PAP specific T-cell activation to sipuleucel-T using interferon gamma (IFNγ) enzyme-linked immunosorbent spot (ELISPOT) measured as cells per 300,000 PBMCs at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination0.90.0 – 1.8
Sipuleucel-T Alone4.80.0 – 1.7
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination7.80.0 – 2.8
Sipuleucel-T Alone10.90.0 – 18.7
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination14.10.0 – 3.7
Sipuleucel-T Alone19.40.0 – 6.5
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination12.20.2 – 5.3
Sipuleucel-T Alone9.00.0 – 5.0
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination10.40.7 – 2.3
Sipuleucel-T Alone1.00.0 – 1.5
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination5.00.3 – 2.8
Sipuleucel-T Alone1.31.3 – 1.3
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3.00.8 – 4.5
Sipuleucel-T Alone0.00.0 – 0.0
PA2024 Specific Antibody (IgM) Response Secondary · Up to 52 weeks

Mean titer of PA2024 specific antibody (IgM) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination1567.9200 – 1600
Sipuleucel-T Alone2253.6350 – 3200
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination108941.719400 – 204800
Sipuleucel-T Alone164114.3102400 – 204800
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination165434.625600 – 204800
Sipuleucel-T Alone214690.9128000 – 307200
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination101422.77200 – 153600
Sipuleucel-T Alone185600.0102400 – 204800
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination56586.416000 – 76800
Sipuleucel-T Alone28800.017600 – 40000
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination37338.93200 – 51200
Sipuleucel-T Alone204800.0204800 – 204800
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination28400.02800 – 30400
PA2024 Specific Antibody (IgG) Response Secondary · Up to 52 weeks

Mean titer of PA2024 specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination382.150.0 – 350
Sipuleucel-T Alone771.462.5 – 800
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination1476.9200.0 – 1600
Sipuleucel-T Alone7878.61000.0 – 5600
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3442.9400.0 – 6400
Sipuleucel-T Alone23272.71600.0 – 6400
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination4191.7350.0 – 4000
Sipuleucel-T Alone15733.3800.0 – 3200
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3568.21000.0 – 6400
Sipuleucel-T Alone7200.04400.0 – 10000
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination2738.9400.0 – 1600
Sipuleucel-T Alone25600.025600.0 – 25600
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3812.5612.5 – 4400
PAP Specific Antibody (IgG) Response Over Time Secondary · Up to 52 weeks

Mean titer of PAP specific antibody (IgG) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination796.450 – 800
Sipuleucel-T Alone1475.0125 – 800
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3765.4400 – 1600
Sipuleucel-T Alone10546.4800 – 5600
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination15125.0800 – 11200
Sipuleucel-T Alone44563.64800 – 25600
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination6554.2625 – 6400
Sipuleucel-T Alone6450.02450 – 12800
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination5354.5400 – 4800
Sipuleucel-T Alone51400.025900 – 76900
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination3916.7400 – 6400
Sipuleucel-T Alone204800.0204800 – 204800
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination5100700 – 8000
PAP Specific Antibody (IgM) Response Secondary · Up to 52 weeks

Mean titer of PAP specific antibody (IgM) response to sipuleucel-T using enzyme-linked immunosorbent assay (ELISA) at baseline and weeks 6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T.

Baseline
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination4714.3250 – 1600
Sipuleucel-T Alone6253.8400 – 3200
Week 6
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination99209.119200 – 51200
Sipuleucel-T Alone112114.316000 – 204800
Week 10
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination183184.625600 – 409600
Sipuleucel-T Alone210909.176800 – 409600
Week 14
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination73250.05200 – 64000
Sipuleucel-T Alone238400.0166400 – 409600
Week 26
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination72363.612800 – 38400
Sipuleucel-T Alone205600.0103600 – 307600
Week 39
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination36425.05600 – 25600
Sipuleucel-T Alone409600.0409600 – 409600
Week 52
GroupValue95% CI
Sipuleucel-T and Radium 223 Combination33200.02800 – 44800
Sipuleucel-T Product Immune Parameters as Assessed by Number of CD54+ Cells Secondary · Up to 4 weeks

Mean number of CD54 + cells

GroupValue95% CI
Sipuleucel-T and Radium 223 Combination2730.31704.8 – 3474.5
Sipuleucel-T Alone2059.11598.2 – 2512.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sipuleucel-T and Radium 223 Combination
Serious: 2/16 (13%)
Deaths: 0/16
Sipuleucel-T Alone
Serious: 1/16 (6%)
Deaths: 0/16

Serious adverse events (3 terms)

ReactionSystemSipuleucel-T and Radium 22…Sipuleucel-T Alone
DyspneaRespiratory, thoracic and mediastinal disorders——
Urinary RetentionRenal and urinary disorders——
AnemiaBlood and lymphatic system disorders——
Other adverse events (21 terms — click to expand)

ReactionSystemSipuleucel-T and Radium 22…Sipuleucel-T Alone
PainGeneral disorders——
DiarrheaGastrointestinal disorders——
ChillsGeneral disorders——
AnemiaBlood and lymphatic system disorders——
NauseaGastrointestinal disorders——
FatigueGeneral disorders——
ConstipationGastrointestinal disorders——
Flu Like SymptomsGeneral disorders——
DizzinessNervous system disorders——
HypertensionVascular disorders——
HeadacheNervous system disorders——
FeverGeneral disorders——
FallInjury, poisoning and procedural complications——
White Blood Cell DecreasedInvestigations——
VomitingGastrointestinal disorders——
Abdominal PainGastrointestinal disorders——
Edema LimbsGeneral disorders——
InsomniaPsychiatric disorders——
Catheter Related InfectionInfections and infestations——
Urinary RetentionRenal and urinary disorders——
Platelet Count DecreasedInvestigations——

Most-reported serious reactions: Dyspnea, Urinary Retention, Anemia.

Data from ClinicalTrials.gov NCT02463799 adverse events section.

Sponsor's own description

This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Genetics and biology of prostate cancer.
    Wang G, Zhao D, Spring DJ, DePinho RA. · · 2018 · cited 527× · PMID 30181359 · DOI 10.1101/gad.315739.118
  2. Re-Emergence of Dendritic Cell Vaccines for Cancer Treatment.
    Saxena M, Bhardwaj N. · · 2018 · cited 231× · PMID 29458962 · DOI 10.1016/j.trecan.2017.12.007
  3. Immunotherapy of Prostate Cancer: Facts and Hopes.
    Bilusic M, Madan RA, Gulley JL. · · 2017 · cited 193× · PMID 28663235 · DOI 10.1158/1078-0432.ccr-17-0019
  4. Recent Advances in Prostate Cancer Treatment and Drug Discovery.
    Nevedomskaya E, Baumgart SJ, Haendler B. · · 2018 · cited 176× · PMID 29734647 · DOI 10.3390/ijms19051359
  5. Sipuleucel-T for the treatment of prostate cancer: novel insights and future directions.
    Handy CE, Antonarakis ES. · · 2018 · cited 124× · PMID 29260582 · DOI 10.2217/fon-2017-0531
  6. Past, Current, and Future of Immunotherapies for Prostate Cancer.
    Boettcher AN, Usman A, Morgans A, VanderWeele DJ, et al · · 2019 · cited 89× · PMID 31572678 · DOI 10.3389/fonc.2019.00884
  7. Radium-223 mechanism of action: implications for use in treatment combinations.
    Morris MJ, Corey E, Guise TA, Gulley JL, et al · · 2019 · cited 87× · PMID 31712765 · DOI 10.1038/s41585-019-0251-x
  8. Current concepts in bone metastasis, contemporary therapeutic strategies and ongoing clinical trials.
    Gdowski AS, Ranjan A, Vishwanatha JK. · · 2017 · cited 83× · PMID 28800754 · DOI 10.1186/s13046-017-0578-1

Verify or expand the search:

Other trials of Radium-223

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02463799.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing