A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

Completed · Phase 2

Conditions studied: Metastatic Prostate Cancer

In brief

This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.

Key facts

Study ID

NCT01981122

Run by

Dendreon

People needed

52

Starts

2013-09-01

Expected to finish

2017-06-30

Last updated by the study team

2018-10-24

Who can join

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

You may qualify if…

• Written informed consent provided prior to the initiation of study procedures.
• Age ≥ 18 years.
• Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
• Metastatic disease as evidenced by bone metastasis or lymph node metastasis.
• Castrate-resistant prostate cancer as demonstrated by one of the following:
• Prostate specific antigen progression.
• Progression of measurable disease.
• Progression of non-measurable disease by soft tissue disease or bone disease.
• Castration levels of testosterone (≤ 50 ng/dL) achieved via medical or surgical castration.
• Serum PSA (Prostate specific antigen) ≥ 2.0 ng/mL.
• Screening ECOG (The Eastern Cooperative Oncology Group )performance status ≤ 1
• Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results obtained ≤ 28 days prior to registration.
• Negative serology test for human immunodeficiency virus 1 and 2.
• Resides within driving distance (round trip within 1 day) of the clinical trial site for the duration of the active phase.

You may not qualify if…

• The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
• Spinal cord compression, imminent long bone fracture, or any other condition that is likely to require radiation therapy and/or steroids for pain control during the active phase.
• History of stage 3 or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease free at the time of registration. Subjects with a history of stage 1 or 2 cancer must have been adequately treated and been disease free for ≥ 3 years at the time of registration.
• History of seizures or of predisposing factors for seizures.
• Child-Pugh Class C hepatic insufficiency.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T, GM-CSF or granulocyte colony stimulating factor (G-CSF).
• Previous treatment with sipuleucel-T or enrollment in a sipuleucel-T trial, regardless of whether the subject received sipuleucel-T or control.
• Previous treatment with enzalutamide.
• Previous treatment with abiraterone acetate.
• Previous treatment with ipilimumab.
• Previous treatment with ketoconazole other than topical use or for treatment of infections (e.g., oral thrush); most recent use must have been ≥ 7 days prior to registration.
• Previous treatment with any immunotherapy or investigational vaccine.
• A requirement for ongoing systemic immunosuppressive therapy. Use of inhaled, intranasal, intra-articular, and topical steroids is allowed. Oral or IV steroids to prevent or treat IV contrast reactions are allowed.
• Previous treatment with chemotherapy for mCRPC, or chemotherapy for any reason ≤ 2 years prior to registration.
• Use of concomitant medications that may lower the seizure threshold or the use of antiseizure medications ≤ 1 year prior to registration.
• Received GM-CSF or G-CSF ≤ 90 days prior to registration.
• Ongoing non-steroidal antiandrogen withdrawal response.
• Any of the following medications or interventions ≤ 28 days prior to registration:
• Radiation therapy, either via external beam or brachytherapy.
• Any systemic steroid. Use of inhaled, intra-nasal, intra-articular, and topical steroids is allowed. Oral or IV steroids to prevent or treat IV contrast reactions are allowed.
• Any systemic therapy for prostate cancer, except for ADT (Androgen deprivation therapy).
• Any investigational product for prostate cancer.
• Major surgery requiring general anesthesia, with the exception of placement of central venous catheters.
• Inducers and inhibitors of cytochrome P450 (CYP) enzyme CYP2C8 (gemfibrozil and rifampin).
• Medications that are metabolized by CYP3A4, CYP2C9, or CYP2C19 that have a narrow therapeutic index.

Where it is running

• Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer and Research Center — Tampa, Florida, United States
• Uro Partners/ RMD Clinical Research — Melrose Park, Illinois, United States
• Fort Wayne Medical Oncology and Hematology, Lutheran Hospital, Parkview Regional Medical Center — Fort Wayne, Indiana, United States
• Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• GU Research Network — Omaha, Nebraska, United States
• North Shore Hematology/Oncology Associates, P.C. — East Setauket, New York, United States
• Associated Medical Professionals of New York, PLLC — Syracuse, New York, United States
• Raleigh Hematology Oncology Associates, D.B.A. Cancer Centers of North Carolina — Raleigh, North Carolina, United States
• Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates, PC — Nashville, Tennessee, United States
• Urology of Virginia — Virginia Beach, Virginia, United States
• Virginia Mason Medical Center, Virginia Mason Hospital — Seattle, Washington, United States
• Northwest Medical Specialties, Rainier Physicians — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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