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

NCT ID: NCT02042053

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-10-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PET/CT

Intervention Type: DEVICE

PET/MRI

Intervention Type: DEVICE

Interventions

PET/CT

Intervention Type: DEVICE

PET/MRI

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dendreon

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Ferrari, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Cancer Center

Locations

New York University Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

NYU S12-03902

Identifier Type: -

Identifier Source: org_study_id