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

NCT01807065 | Completed Phase 2 Results DMC

• 2 other identifiers: 12367NCI-2013-00542
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

Adenocarcinoma of the Prostate; Bone Metastases; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Soft Tissue Metastases; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  Until progression or death, Up to 2 years.

Secondary Outcomes (1)

• Number of Participants With Grade 2 or Above Adverse Events

  Up to 60 weeks

Study Arms (2)

Arm A (sipuleucel-T)

EXPERIMENTAL

Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.

Biological: sipuleucel-T; Other: laboratory biomarker analysis

Arm B (radiation therapy, sipuleucel-T)

EXPERIMENTAL

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

Biological: sipuleucel-T; Radiation: external beam radiation therapy; Other: laboratory biomarker analysis

Interventions

sipuleucel-T BIOLOGICAL

Given IV

Also known as: APC 8015, Provenge

Arm A (sipuleucel-T); Arm B (radiation therapy, sipuleucel-T)

external beam radiation therapy RADIATION

Undergo external beam radiation therapy

Also known as: EBRT

Arm B (radiation therapy, sipuleucel-T)

laboratory biomarker analysis OTHER

Correlative studies

Arm A (sipuleucel-T); Arm B (radiation therapy, sipuleucel-T)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

South Pasadena Cancer Center

Pasadena, California, 91030, United States

Location

Huntsman Cancer Institute, Univ. of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 30682445 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-T

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Cy Stein, MD, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: June 7, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2019-06

Locations

US (3)