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Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Phase 2
18 Years
Not Enrolling
Metastatic Castrate-resistant Prostate Cancer, mCRPC

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Trial Information

Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

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

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 bisphosponate 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.


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

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.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Raquibul Hannan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center


United States: Food and Drug Administration

Study ID:

STU 102012-026



Start Date:

June 2013

Completion Date:

July 2015

Related Keywords:

  • Metastatic Castrate-resistant Prostate Cancer
  • mCRPC
  • Prostatic Neoplasms



University of Texas Southwestern Medical Center Dallas, Texas