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

NCT ID: NCT01818986

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-10
• Study Completion Date: 2021-05-25

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

Conditions

Metastatic Castrate-resistant Prostate Cancer; mCRPC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm one

Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)

Group Type: EXPERIMENTAL

Sipuleucel-T

Intervention Type: DRUG

Stereotactic Ablative Body Radiation

Intervention Type: RADIATION

Interventions

Sipuleucel-T

Intervention Type: DRUG

Stereotactic Ablative Body Radiation

Intervention Type: RADIATION

Other Intervention Names

Provenge; SABR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Raquibul Hannan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquibul Hannan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 102012-026

Identifier Type: -

Identifier Source: org_study_id