Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sipuleucel-T; Placebo
Intervention description: Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.; Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Summary:

      Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not
      yet known if vaccine therapy is effective for prostate cancer.

      Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in
      treating patients who have metastatic prostate cancer that has not responded to hormone
      therapy.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Metastatic disease as evidenced by soft tissue and/or bony metastases.

          -  Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.

          -  Tumor progression after hormonal therapy.

          -  Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for
             treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be
             documented for all subjects including subjects who underwent orchiectomy as therapy
             for cancer of the prostate.

          -  A subject is eligible if he initially responded to antiandrogen withdrawal (> 25%
             decrease in PSA) but at the time of registration demonstrated tumor progression. A
             subject is eligible if he failed to respond to antiandrogen withdrawal.

          -  Subjects have no cancer-related pain and do not regularly require analgesics for
             cancer-related pain.

          -  ECOG Performance Status of 0 or 1.

          -  Life expectancy of at least 16 weeks.

          -  Adequate hematologic, renal, and liver function.

        Exclusion Criteria include:

          -  Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive
             effusions (e.g., pleural effusions or ascites).

          -  Metastatic disease expected to be in need of radiation therapy within 4 months.

          -  Concurrent therapy with experimental agents.

          -  Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any
             reason other than treatment of prostate cancer within the previous 6 months without
             prior approval.

        Please note that there are additional eligibility criteria. The study center will determine
        if you meet all of the criteria.