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Adenocarcinoma of the ProstatePhase 2NCT01807065

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

A Phase 2 study testing sipuleucel-T, external beam radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Bone Metastases, run by City of Hope Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase II trial studies how well giving 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
sipuleucel-T, external beam radiation therapy and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
3 sitesUnited States
Study dates
25 Jun 2013to 31 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented adenocarcinoma of the prostate
  • Life expectancy of >= 6 months, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • 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
  • 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
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  • Non-measurable disease:
  • Soft tissue disease: The appearance of 1 or more lesions, and/or unequivocal 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
  • White blood cell (WBC) >= 2,500 cells/uL
  • Absolute neutrophil count (ANC) >= 1,000 cells/uL
  • Platelet count >= 75,000 cells/uL
  • Hemoglobin (HgB) >= 9.0 g/dL
  • Creatinine =< 2.5 mg/dL
  • Total bilirubin =< 2 x institutional upper limit of normal (ULN)
  • 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

Who cannot join

  • The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Treatment with chemotherapy within 3 months of 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
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  • Any other systemic therapy for prostate cancer (except for medical castration)
  • History of external beam radiation therapy to metastatic sites within 1 year of enrollment to the study
  • Participation in any previous study involving sipuleucel-T
  • Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
  • 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
  • A requirement for systemic immunosuppressive therapy for any reason
  • 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
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • South Pasadena Cancer Center

    Pasadena, California, 91030

  • Huntsman Cancer Institute, Univ. of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer

This randomized phase II trial studies how well giving 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 giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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 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.

Being tested
sipuleucel-T, external beam radiation therapy, laboratory biomarker analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sipuleucel-TBiological

    Also called APC 8015, Provenge

    Given IV

  • external beam radiation therapyRadiation

    Also called EBRT

    Undergo external beam radiation therapy

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01807065
Study groupRoleWhat they receive
Arm A (sipuleucel-T)ExperimentalPatients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.
Receives: Biological: sipuleucel-T; Other: laboratory biomarker analysis
Arm B (radiation therapy, sipuleucel-T)ExperimentalPatients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.
Receives: Biological: sipuleucel-T; Radiation: external beam radiation therapy; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Estimated using the product-limit method of Kaplan and Meier.

    Progression is defined as one or more of the following:

    20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.

    Measured: Until progression or death, Up to 2 years.

Secondary outcomes (1)

  1. Number of Participants With Grade 2 or Above Adverse Events

    Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

    Measured: Up to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2013 (estimated)
  2. Study start25 Jun 2013
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807065
Sponsor's protocol ID
12367
Other IDs
NCI-2013-00542
Status last verified
Aug 2026
First submitted
6 Mar 2013
Last updated
11 Sep 2026
Data monitoring committee
Yes

Publications

  • Twardowski P, Wong JYC, Pal SK, Maughan BL, Frankel PH, Franklin K, Junqueira M, Prajapati MR, Nachaegari G, Harwood D, Agarwal N. Randomized phase II trial of sipuleucel-T immunotherapy preceded by sensitizing radiation therapy and sipuleucel-T alone in patients with metastatic castrate resistant prostate cancer. Cancer Treat Res Commun. 2019;19:100116. doi: 10.1016/j.ctarc.2018.100116. Epub 2018 Dec 20.

    PubMed 30682445

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sipuleucel-T, external beam radiation therapy and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Bone Metastases, run by City of Hope Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Until progression or death, Up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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Clinical Trial NCT01807065 | AzTrials