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

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02042053

Run by

NYU Langone Health

People needed

10

Starts

2014-01-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• New York University Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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