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Key inclusion criteria:
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1) Histologically documented adenocarcinoma of the prostate any Gleason Score, confirmed by the Mater Health Services Pathology prior to registration.
2) Metastatic, androgen independent adenocarcinoma of the prostate. Metastatic disease is defined by soft tissue and/or bony metastases on imaging or pathological studies (Computed Tomography, bone scan or histology). Androgen independent adenocarcinoma of the prostate is defined by a rising serum Prostate Specific Antigen (PSA) level confirmed on two consecutive PSA values, at least 28 days apart, each ?6.5ng/mL using the Architect method, and = 50% above the minimum PSA observed during castration therapy or = 50% above the pretreatment value if there was no response to androgen deprivation therapy. At least one serum PSA estimation must be conducted by Mater Health Services Pathology.
3) Adequate androgen suppression as evidenced by a serum testosterone level ?50ng/dL.
4) Life expectancy of at least 6 months.
5) Age 18-80 years.
6) Performance status Eastern Cooperatic Oncology Group ?2
(7) Adequate haematological reserve for apheresis and dendritic cell preparation as defined by:
I. Neutrophils > 1.8x109/L.
II. Lymphocytes > 1x109/L.
III. Haemoglobin > 110g/L.
IV. Platelets > 150x109/L.
8) HLA-A*0201 positive.
9) Written informed consent. |
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Key exclusion criteria:
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1) Intercurrent participation in another clinical trial of Prostate Cancer therapy.
Justified as outcomes and adverse events may be attributed to either therapy.
2) Known brain metastasis or spinal cord compression.
Justified as inflammation in these critical sites is a possibility and patient safety is paramount. Also these conditions require specific intervention which influences interpretation of data collected. They also carry poor prognostic implications, which may affect ability of the patient to complete the trial.
3) Significant bony metastatic disease involving axial skeleton with risk of spinal cord compression or pathological fracture.
Justified as these conditions require specific intervention which influences interpretation of data collected. They also carry poor prognostic implications, which may affect ability of the patient to complete the trial.
4) Progressive metastatic disease, as defined as increasing symptoms requiring change in medication within the previous 4 weeks.
Justified as disease progression requiring change in medication carries prognostic implications which influences ability of patients to complete the trial. Also, new medication may have side effects which could not be distinguished from adverse events.
5) Treatment with chemotherapy, bisphosphonate therapy, external beam radiation therapy, surgery, systemic corticosteroids, megestrol acetate, diethylstilboestrol (DES), ketoconazole, 5-alpha-reductase inhibitors, calcitriol, Interferon or other immunomodulatory medication, strontium, or any other systemic therapy for prostate cancer within 28 days of registration (excluding androgen deprivation therapy).
Justified as disease requiring these treatments is advanced with poor prognosis, or the treatments themselves are likely to have side effects which could not be distinguished from adverse events due to the trial vaccine.
6) Receipt of investigational vaccine within 1 year of registration.
Justified as it would not be possible to determine which vaccine adverse events could be attributed to.
7) Receipt of any other investigational product within 28 days of registration.
Justified as it would not be possible to determine which investigational product adverse events could be attributed to.
8) Antibiotic therapy or infection within 1 week prior to registration, including unexplained fever (temp greater than 100.5 F or 38.1 C).
Justified as current or partially treated infection is a contraindication to vaccination.
9) No vaccinations against infectious disease, including influenza vaccine, in the three months prior to and during the trial.
Justified as recent vaccination may effect trial vaccine efficacy, or interact with the trial vaccine.
10) Intercurrent medical, surgical or psychiatric condition, which, in the opinion of the medical monitor, may interfere with the conduct or safety of the trial.
Justified as patient safety is paramount.
11) Positivity for humn immunodeficiency virus 1/2, human T cell lymphotropic virus 1/2, Hepatitis B, Hepatitis C or Syphilis (VDRL).
Justified as these conditions cause immunosuppression which may impact on trial vaccine efficacy. |
