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

Study ID
STU 102012-026

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact


Principal Investigator

Official Title

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

Brief Overview


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

Participant Eligibility


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.