Interested in a Clinical Trial?

Learn More

Prostate Clinical Trials

header

SLUHN 2015-62

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Nicole Kern, BS
    484-503-4154 

    Nicole.kern@sluhn.org
  • Treatment Agent: Dendritic Cells DCVAC

    Synopsis: The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.

    • Male 18 years and older.
    • Histologically or cytologically confirmed prostate adenocarcinoma.
    • Presence of skeletal and/or soft-tissue/visceral/nodal metastases according to one of the following criteria:
    • Confirmed pathological fracture related to the disease.

    OR

    • Confirmation of distant bone and/or soft-tissue and/or visceral metastases through at least one imaging modality including CT or MRI or scintigraphy scan (confirmation by independent review facility (IRF) required)

    OR

    • Positive pathology report of metastatic lesion.
    • Disease progression despite androgen deprivation therapy (ADT) as indicated by:
    • PSA increase that is ≥ 25% and ≥ 2 ng/mL above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later.

    OR

    • Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v1.1 criteria (confirmation by IRF required);

    OR

    • Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
    • Maintenance of castrate condition: Subjects, who have not had a surgical orchiectomy, must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to reach levels of serum testosterone of ≤ 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening.
    • Laboratory criteria:
    • White blood cells greater than 4,000/mm3 (4.0 x109/L).
    • Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
    • Hemoglobin of at least 10 g/dL (100g/L).
    • Platelet count of at least 100,000/mm3 (100 x109/L).
    • Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted).
    • Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <1.5 times the ULN.
    • Life expectancy of at least 6 months based on Investigator´s judgment.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    • At least 4 weeks after surgery or radiotherapy before randomization.
    • A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
    • Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
    • Signed informed consent including patient’s ability to comprehend its contents.
    • Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
    • Current symptomatic spinal cord compression requiring surgery or radiation therapy.
    • Prior chemotherapy for prostate cancer
    • Patient co-morbidities:
    • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
    • HIV positive, HTLV positive.
    • Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis.
    • Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
    • Clinically significant cardiovascular disease including:
    • symptomatic congestive heart failure.
    • unstable angina pectoris.
    • serious cardiac arrhythmia requiring medication.
    • uncontrolled hypertension.
    • myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) < 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
    • Pleural and pericardial effusion of any CTCAE grade.
    • Peripheral neuropathy having a CTCAE ≥ grade 2.
    • History of active malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
    • Active autoimmune disease requiring treatment.
    • History of severe forms of primary immune deficiencies.
    • History or anaphylaxis or other serious reaction following vaccination.
    • Known hypersensitivity to any constituent in of the DCVAC/PCa or placebo product
    • Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial.
    • Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within 6 months before randomization.
    • Ongoing systemic immunosuppressive therapy for any reason.
    • Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists), to exclude possible antiandrogen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of antiandrogen withdrawal response.
    • Treatment with immunotherapy against PCa within 6 months before randomization.
    • Treatment with radiopharmaceutical within 8 weeks before randomization.
    • Participation in a clinical trial using experimental therapy within 4 weeks before randomization.
    • Participation in a clinical trial using immunological experimental therapy (e.g., monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
    • Refusal to sign the informed consent.