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PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02042053
Recruitment Status : Terminated (Due to PI leaving the institution)
First Posted : January 22, 2014
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Dendreon
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (PET/MR) imaging measures for the prediction of immunological response to Sipuleucel T (SipT) therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: PET/CT Device: PET/MRI Not Applicable

Detailed Description:

Recent studies of treatments of prostate cancer through stimulation of adaptive immune response have indicated the linear measurements by computed tomography (CT) and nuclear scans used to assess tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) were inadequate and the value of progression-free survival (PFS) as a predictive surrogate endpoint of survival was lost.

The objective of this study is to provide an initial evaluation of the utility of PET/MR imaging measures for the prediction of immunological response to SipT therapy. Investigators expect to identify an"imaging-signature" of response to SipT based on changes in metabolism, perfusion, oxygenation and cellularity of metastasis and its correlation with immunological and clinical response. This approach will help elucidate the mechanism of activity and dynamics of immune antitumor responses to SipT in vivo and to identify new parameters of tumor response and predictive value than current RECIST and PFS standards.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET/MR
Patients treated with SipT (standard of care) undergo FDG-PET/MRI, NaF-PET/CT and blood drawing at 3 time points: baseline, Day 7 after the last SipT infusion, Week 10 after the last SipT infusion.
Device: PET/CT
Device: PET/MRI



Primary Outcome Measures :
  1. Percentage of patients with imaging parameter change(s) among the patients with immunological response [ Time Frame: up to 14 weeks ]
    NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV (standard uptake value) max on FDG-PET and NaF-PET, in MRI-ADC (apparent diffusion coefficient ) value, in MRI contrast enhancement, and in T2 lesion size will be measured.


Secondary Outcome Measures :
  1. Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: up to 14 weeks ]
    NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV max on FDG-PET and NaF-PET, in MRI-ADC value, in MRI contrast enhancement, and in T2 lesion size will be measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men ≥ 18 years of age
  • History of prostate cancer treated with androgen deprivation
  • Serum Testosterone levels <50 ng/mL
  • Established asymptomatic or minimally symptomatic metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status≤2
  • Accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent
  • Accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent
  • Patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with Zytega or ketoconazole prior to enrollment are eligible
  • Patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone <2 mg daily or fludrocortisone 0.1 mg daily orally)

Exclusion Criteria:

  • Chemotherapy or radiation therapy treatment within 21 days of Sipuleucel-T
  • ECOG performance status >2
  • Prior treatment with Sipuleucel-T
  • Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin
  • Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
  • Active spinal cord compression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042053


Locations
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United States, New York
New York University Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Dendreon
Investigators
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Principal Investigator: Anna Ferrari, MD New York University Cancer Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02042053     History of Changes
Other Study ID Numbers: NYU S12-03902
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
imaging
diagnostic
castration resistant
metastatic prostate cancer
immunotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases