Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and over12367
NCI-2013-00542, 097472, NCT01807065

Trial Description



This randomized phase II trial studies how well sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer.

Further Study Information


I. To assess the feasibility, based on percent able or willing to receive all three infusions of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to a single site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.


I. To assess the effect of radiation therapy to single metastasis on immune response (antibody and T-cell proliferation to prostate acid phosphate [PAP] and fusion protein PA2024) generated by sipuleucel-T immunotherapy.

II. To assess the effect of external beam radiotherapy to single metastasis on prostate specific antigen (PSA) response to therapy with sipuleucel-T.

III. To assess the effect of external beam radiotherapy to single metastasis on radiographic response rate to therapy with sipuleucel-T.

IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need for subsequent therapy for prostate cancer.

V. To assess the toxicity associated with sipuleucel-T +/- radiation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes on days 22, 36, and 50.

ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up until week 60.

Eligibility Criteria

Inclusion Criteria:

White blood cell (WBC) >= 2,500 cells/uL

Histologically documented adenocarcinoma of the prostate

Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN

Prior chemotherapy with 0-2 regimens is allowed

Prior radiation therapy to prostate or prostate bed is allowed provided it occurred > 3 months before enrollment to the study

Hemoglobin (HgB) >= 9.0 g/dL

Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen or pelvis

Absolute neutrophil count (ANC) >= 1,000 cells/uL

Platelet count >= 75,000 cells/uL

Total bilirubin =< 2 x institutional upper limit of normal (ULN)

Life expectancy of >= 6 months, Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Creatinine =< 2.5 mg/dL

Castration resistant prostatic adenocarcinoma; subjects must have current or historical evidence of disease progression despite castrated level of testosterone (< 50 ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy; disease progression has to be demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease as defined below:

PSA: two consecutive rising PSA values, at least 7 days apart

Measurable disease: >= 20% increase in the sum of the longest diameters of all measurable lesions or the development of any new lesions; the change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response

Non-measurable disease:

  • Soft tissue disease: the appearance of 1 or more lesions, and/or equivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response
  • Bone disease: appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression

Exclusion Criteria:

Moderate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registration

Treatment with any of the following medications or interventions within 28 days of registration:

Systematic corticosteroids; use of inhaled, intranasal, and topical steroids is acceptable

Any other systemic therapy for prostate cancer (except for medical castration)

Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression

Participation in any previous study involving sipuleucel-T

History of external beam radiation therapy to metastatic sites within 1 year of enrollment to the study

Concurrent other malignancy with the exception of:

Cutaneous squamous cell and basal carcinomas

Adequately treated stage 1-2 malignancy

Adequately treated stage 3-4 malignancy that has been in remission for >= 2 years at the time of registration

Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study's objectives

A requirement for systemic immunosuppressive therapy for any reason

ECOG performance status > 2

Treatment with chemotherapy within 3 months of registration

Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5 degrees Fahrenheit [F] or 38.1 degrees Celsius [C]) within 1 week prior to registration

The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

City of Hope Comprehensive Cancer Center

  • National Cancer Institute
Przemyslaw W. Twardowski, Principal Investigator

Trial Sites



City of Hope Comprehensive Cancer Center

Przemyslaw W. Twardowski
Ph: 626-256-4673ext68218

Przemyslaw W. Twardowski
Principal Investigator

South Pasadena

City of Hope South Pasadena

Stephen C. Koehler
Ph: 626-396-2900

Stephen C. Koehler
Principal Investigator

Salt Lake City

Huntsman Cancer Institute/University of Utah

Neeraj Ramvishal Agrawal
Ph: 919-785-4878

Neeraj Ramvishal Agrawal
Principal Investigator

Link to the current record.
NLM Identifer NCT01807065

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.