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

Prostate Cancer Clinical Trial

Official title:

Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042053
• Other study ID #: NYU S12-03902
• Status: Terminated
• Phase: N/A
• First received: January 17, 2014
• Last updated: July 13, 2017
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• PET/CT

• PET/MRI

Locations

Country	Name	City	State
United States	New York University Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with imaging parameter change(s) among the patients who respond per Response Evaluation Criteria In Solid Tumors (RECIST)	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.	up to 14 weeks