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Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT01818986
Recruitment Status : Active, not recruiting
First Posted : March 27, 2013
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Raquibul Hannan, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE March 6, 2013
First Posted Date  ICMJE March 27, 2013
Last Update Posted Date May 26, 2021
Actual Study Start Date  ICMJE July 10, 2013
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2013)
Time to progression [ Time Frame: 4 years ]
evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2013)
Immune response [ Time Frame: 26 weeks ]
Immune response will be measured using ELISpot assay, T-cell proliferation assay or ELISA. An immune endpoint will be reached by the patient if a >100% increase in immune response is measured by ANY of the assays
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Official Title  ICMJE Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Brief Summary In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Castrate-resistant Prostate Cancer
  • mCRPC
Intervention  ICMJE
  • Drug: Sipuleucel-T
    Other Name: Provenge
  • Radiation: Stereotactic Ablative Body Radiation
    Other Name: SABR
Study Arms  ICMJE Experimental: arm one
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
Interventions:
  • Drug: Sipuleucel-T
  • Radiation: Stereotactic Ablative Body Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 20, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2013)
41
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Biopsy proven prostate cancer
  2. Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl). Medical castration should continue until disease progression
  3. Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
  4. PSA ≥ 5 ng/ml
  5. Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
  6. Adequate hematologic, renal, and liver function
  7. Previous treatment with surgery, radiation or hormonal therapy is allowed.
  8. Performance status ECOG 0 or 1.
  9. Life expectancy of at least 6 months
  10. Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C.
  11. Age ≥ 18 years.
  12. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  1. Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
  2. Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
  3. Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  4. Subjects with malignant pleural effusions and malignant ascites
  5. Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
  6. Systemic immunosuppressive therapy in the past 28 days.
  7. Use of any of the following within the past 28 days: Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate, Ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week).
  8. Inability to tolerate contrast dye for baseline CT imaging.
  9. Initiation or discontinuation of biphosphonate use within past 28 days.
  10. Subjects with pathologic long-bone fractures
  11. Subjects with spinal cord compression
  12. Paget's disease of bone.
  13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01818986
Other Study ID Numbers  ICMJE STU 102012-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raquibul Hannan, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raquibul Hannan, MD, PhD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP