Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
Condition: Prostatic Neoplasm; Prostate Cancer; Prostatic Adenocarcinoma
MeSH terms: Prostatic Neoplasms; Neoplasms; Adenocarcinoma
Intervention: sipuleucel-T; leuprolide acetate
Intervention description: Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).; 45.0 mg depot injection, 2 doses 6 months apart
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immune therapy; Cancer vaccine; Therapeutic vaccine; Therapeutic cancer vaccine; Vaccine; Dendritic cells; PSA; Androgen deprivation therapy; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms; Prostatic Diseases; Androgens; Hormones; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Immunology; Hormone therapy; Immunotherapy; Luteinizing hormone-releasing hormone (LHRH)

Summary:

      The main purpose of this study was to determine whether ADT started before or after
      sipuleucel-T led to a better immune system response. This study also evaluated the safety of
      sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of
      sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hormone-sensitive prostate cancer

          -  Non-metastatic disease, as evidenced by negative bone scan or computed tomography of
             the abdomen and pelvis

          -  ECOG performance status ≤ 1

          -  Histologically documented prostate cancer

          -  Prior primary therapy for prostate cancer

          -  Rising PSA with a PSADT of ≤ 12 months

          -  Testosterone ≥ 200 ng/dL ≤ 28 days of registration

          -  Adequate hematologic, renal, and liver function

          -  Must live in a permanent residence within a comfortable driving distance (round-trip
             within one day) to the clinical research site

        Exclusion Criteria:

          -  Requires systemic ongoing immunosuppressive therapy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sipuleucel-T or GM-CSF

          -  Prior sipuleucel-T therapy

          -  Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total

          -  If subject has a history of any other stage III/IV malignancy, the subject must be
             disease free and off any malignancy-related treatment for at least 10 years. If the
             subject has a history of any stage I-II malignancy, the subject must be disease free
             and off any malignancy-related treatment for at least 5 years.

          -  Prior experimental immunotherapy or on an experimental clinical trial within 1 year

          -  Received denosumab or XRT ≤ 6 months prior to registration

          -  Received chemotherapy or GM-CSF ≤ 90 days prior to registration

          -  Received any of the following medications or interventions ≤ 28 days prior to
             registration

               -  major surgery requiring general anesthesia

               -  systemic immunosuppressive therapy

               -  other prescription treatment for prostate cancer

          -  Active infection within 1 week of registration

          -  Likely to receive XRT or surgery for prostate cancer during the study period

          -  Any medical intervention, any other condition, or any circumstances that could
             compromise the study.