NCT02042053

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

January 17, 2014

Last Update Submit

July 13, 2017

Conditions

Prostate Cancer

Keywords

imagingdiagnosticcastration resistantmetastatic prostate cancerimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with imaging parameter change(s) among the patients with immunological response

    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.

    up to 14 weeks

Secondary Outcomes (1)

  • Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST)

    up to 14 weeks

Study Arms (1)

PET/MR

EXPERIMENTAL

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/CTDevice: PET/MRI

Interventions

PET/CTDEVICE
PET/MR
PET/MRIDEVICE
PET/MR

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Anna Ferrari, MD

    New York University Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 22, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

US(1)