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

NCT01818986 | Completed Phase 2 Results DMC

• 1 other identifier: STU 102012-026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  To 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. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[49\] recommendations and as used in the Phase III clinical trial by Kantoff et. al.\[10\]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.

  4 years

Secondary Outcomes (7)

• Immune Response

  6 week

• Overall Survival (OS)

  60 months

• Progression Free Survival (PFS)

  4 years

• Biochemical Progression Free Survival (bPFS)

  4 years

• Prostate Cancer-specific Survival (PCaSS)

  4 years

Study Arms (1)

arm one

EXPERIMENTAL

Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)

Drug: Sipuleucel-T; Radiation: Stereotactic Ablative Body Radiation

Interventions

Sipuleucel-T DRUG

Also known as: Provenge

arm one

Stereotactic Ablative Body Radiation RADIATION

Also known as: SABR

arm one

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven prostate cancer
• 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
• 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.
• PSA ≥ 5 ng/ml
• Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
• Adequate hematologic, renal, and liver function
• Previous treatment with surgery, radiation or hormonal therapy is allowed.
• Performance status ECOG 0 or 1.
• Life expectancy of at least 6 months
• Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C.
• Age ≥ 18 years.
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
• Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
• 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.
• Subjects with malignant pleural effusions and malignant ascites
• Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
• Systemic immunosuppressive therapy in the past 28 days.
• 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).
• Inability to tolerate contrast dye for baseline CT imaging.
• Initiation or discontinuation of biphosphonate use within past 28 days.
• Subjects with pathologic long-bone fractures
• Subjects with spinal cord compression
• Paget's disease of bone.
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

sipuleucel-T

Results Point of Contact

• Title: Dr. Raquibul Hannan
• Organization: University of Texas Southwestern Medical Center Dallas

raquibul.Hannan@UTSouthwestern.edu

214-645-7696

Study Officials

• Raquibul Hannan, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 27, 2013
• Study Start: July 10, 2013
• Primary Completion: December 20, 2019
• Study Completion: May 25, 2021
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-04

Locations

US (1)