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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/9/2019
Start Date:July 10, 2013
End Date:December 2020
Contact:Raquibul Hannan, MD, PhD
Phone:214-645-8525

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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)

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


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.
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-8525
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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