Phase 2
N=20
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Metastatic Castrate-resistant Prostate Cancer · mCRPC
Bottom Line
View on ClinicalTrials.gov: NCT01818986 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Time to Progression — 11.2 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sipuleucel-T (Drug); Stereotactic Ablative Body Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
11.2 | — |
| SECONDARY Immune Response |
50 | — |
| SECONDARY Overall Survival (OS) |
76.8 | — |
| SECONDARY Progression Free Survival (PFS) |
10.4 | — |
| SECONDARY Biochemical Progression Free Survival (bPFS) |
12.5 | — |
| SECONDARY Prostate Cancer-specific Survival (PCaSS) |
5 | — |
| SECONDARY Adverse Events |
51; 8; 4 | — |
| SECONDARY Cost Effectiveness and Health-related Quality Adjusted Life |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- Biopsy proven prostate cancer
- Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone ( 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.
Data sourced from ClinicalTrials.gov (NCT01818986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.