Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients with metastatic castrate-resistant Prostate Cancer (mCRPC)
We propose a single-arm, open-label, phase ii trial of Sipuleucel-T and SaBR administered concurrently. The safety profile of both SaBR and Sipuleucel-T is excellent and therefore there are limited concerns for toxicity when they are administered concurrently. Given the three randomized phase iii clinical trials of Sipuleucel-T available for comparision and historic control, a two arm trial is not necessary. However, this limits the study populations that were present in those trials, which are asymptomatic and minimally symptomatic mCRPC patients.
1 Biopsy proven prostate cancer
2 Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl)
2.1 Medical castration should continue until disease progression
3 Radiographic evidence of metastatic disease documented with bone scan or CT scan
3.1 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 patients
5.1. Visual Analog Scale (VAS) <= 4
5.2. No narcotic use in the last 21 days
6 Adequate hematologic, renal, and liver function as evidenced by the following:
----White blood cell (WBC) >= 2,500 cells/[MICRO-SYMBOL]L
----Absolute neutrophil count (ANC) >= 1,000 cells/[MICRO-SYMBOL]L
----Platelet Count >= 100,000 cells/[MICRO-SYMBOL]L
----Hemoglobin (HgB) >= 9.0 g/dL
----Creatinine <= 2.0 mg/dL
----Total Bilirubin <= 2 x upper limit of normal (ULN)
----Aspartate aminotransaminase (AST, SGOT) <= 2.5 x ULN
----Alanine aminotransaminase (ALT, SGPT) <= 2.5 x ULN
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.