A Single Arm Open-label, Phase II Study of Sipuleucel-T with Bipolar Androgen Therapy in Men with Metastatic Castration-resistant Prostate Cancer
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
• Written informed consent obtained prior to the initiation of study procedures.
• Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.
• Histologically confirmed adenocarcinoma of the prostate.
• Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).
• Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:
‣ By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
⁃ By measurable disease: Progressive disease by RECIST v1.1 criteria
⁃ By non-measurable disease
• i. Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
∙ ii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.
• Castration status confirmed by serum testosterone level \<50ng/dL
• ECOG Performance Status of 0 or 1.
• Adequate liver function:
‣ Bilirubin \<2.0 x institutional upper limit of normal (UNL)
⁃ AST (SGOT) \<2.5 x UNL
⁃ ALT (SGPT) \<2.5 x UNL
• Acceptable renal function
• a) Serum creatinine \<2.0 x UNL
• Acceptable hematologic function:
‣ Absolute neutrophil count (ANC) \> 1.0 x10\^9 cells /L)
⁃ Platelet counts \> 100 x 10\^9 / L)
⁃ Hemoglobin \>9 g/dL