MC# 18-19 - A Randomized Phase III, Open-Label Trial Of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

  • Agent(s): Sipuleucel-T
  • Disease Type(s): Prostate
  • Phase(s): III
  • Drug Classification(s): Targeted Therapy, Immunotherapy
  • Molecular Target(s): PAP, GM- CSF

Mechanism of Action

Provenge® (Sipuleucel-T) is an autologous cellular immunotherapy designed to stimulate a patient’s own immune system against cancer.


In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of Sipuleucel-T compared to the standard of care treatment
  • If research tests can be used in the future to predict who will benefit from Sipuleucel-T
  • How proteins that indicate the status of disease are affected with use of Sipuleucel-T
Inclusion Criteria
  • Age is ≥ 18 years
  • Written informed consent provided prior to the initiation of study procedures
  • Histologically proven adenocarcinoma of the prostate diagnosed (ultrasound guided prostate biopsy with 10≥ cores) ≤12 months of Screening. All biopsy slides with subject information redacted must be submitted for BICR.
  • Prostate cancer determined by BICR as either:
    • ISUP Grade Group 1 with 3 or more cores positive or 1 core positive with ≥50% cancer involvement
    • ISUP Grade Group 2 (any number of cores)
  • Subject consents to standard of care for biopsy frequency of 2 on-study prostate biopsies and to provide biopsy tissue for study endpoint analysis.
  • Estimated life expectancy ≥ 10 years
  • Candidate for primary curative therapy (e.g., surgery or radiation) if prostate cancer progression occurs
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate baseline hematologic, renal, and liver function tests as evidenced by laboratory test results within the following ranges ≤30 days prior to randomization
    • White blood cell (WBC) count ≥ 3.0 x 10^6 cells/mL
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^6 cells/mL
    • Platelet count ≥ 1.0 x10^6 cells/mL
    • Hemoglobin (Hgb) ≥ 10.0 g/dL
    • Creatinine ≤ 1.5 mg/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) ≤ 2 x ULN
    • Aspartate aminotransferase (AST) ≤ 2 x ULN
Exclusion Criteria
  • Former therapy for prostate cancer (local or systemic)
  • Any previous prostatic surgical procedure that significantly changes the anatomy of prostate (at the discretion of sponsor’s Medical Monitor)
  • Any investigational product received for prostate cancer
  • Prostate biopsy specimen reveals neuroendocrine or small cell features
  • Primary Gleason score is ≥ 4 or any Gleason pattern 5
  • Any evidence of locally advanced, regional or metastatic disease, including regional and distant lymph node enlargement (Nodes ≥1.5 cm in the short axis are considered pathologic and measurable)
  • A history of a cerebrovascular event (CVE) or transient ischemic attack (TIA)
  • Subject has used a 5-alpha-reductase inhibitor (e.g., finasteride or dutasteride) continuously for ≥ 6 months and within 6 months prior to study Screening
  • Subject has a history of any other stage I-IV malignancy, except for basal or squamous cell skin cancer. The subject must be disease free and off any malignancy-related treatment for at least 5 years.
  • Subject has prior use within 30 days of study Screening of any herbal, dietary, or alternative anti-cancer treatment or product, such as PC-SPES (or PC-x product), saw palmetto, ketoconazole, an estrogen-containing nutraceutical, or high dose calcitriol (>0.5 μg/day). The Investigator will consider herbal therapies on a case-by-case basis to determine whether they fall into the category of prohibited medications based on their potential for hormonal or anti-cancer or anti-cancer properties.
  • Need for systemic chronic immunosuppressive therapy (e.g., anti-tumor necrosis factor alpha monoclonal antibodies, glucocorticoids)
  • Any uncontrolled, concurrent illness including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), symptomatic congestive heart failure (New York Classification III-IV) or unstable angina pectoris within the last 6 months, or psychiatric illness that would limit compliance with study requirements
  • Hypogonadal (T <200 ng/dL) or on continuous testosterone replacement therapy
  • Positive serology for HIV-1, HIV-2 or HTLV-1, HTLV-2
  • Active hepatitis B or C
  • Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator or the sponsor’s Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study’s objectives


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 18-19