Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Overview
- Phase
- Phase 2
- Intervention
- Sipuleucel-T
- Conditions
- Metastatic Castrate-resistant Prostate Cancer
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Time to Progression
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Raquibul Hannan
Principal Investigator
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 patients
- •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
- •Life expectancy of at least 6 months
Exclusion Criteria
- •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
Arms & Interventions
arm one
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
Intervention: Sipuleucel-T
arm one
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
Intervention: Stereotactic Ablative Body Radiation
Outcomes
Primary Outcomes
Time to Progression
Time Frame: 4 years
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/.
Secondary Outcomes
- Overall Survival (OS)(60 months)
- Progression Free Survival (PFS)(4 years)
- Biochemical Progression Free Survival (bPFS)(4 years)
- Immune Response(6 week)
- Prostate Cancer-specific Survival (PCaSS)(4 years)
- Adverse Events(60 months)
- Cost Effectiveness and Health-related Quality Adjusted Life(4 years)