EUCTR2010-021196-85-PLActive, not recruitingPhase 1
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer - PROSPECT
Bavarian Nordic, Inc0 sites1,200 target enrollmentStarted: February 11, 2013Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1. Signed Informed Consent
- •2.Men, =18 years of age with documented asymptomatic or minimally
- •symptomatic metastatic castration-resistant prostate cancer.
- •3. Castrate testosterone level < 50 ng/dl
- •4. Documented progressive disease post surgical castration or during
- •androgen suppression therapy or during complete androgen blockade
- •therapy and withdrawal. Documented by either criterion a (Radiological
- •progression), OR criterion b (PSA progression).
- •a. Radiological progression defined as any new/enlarging bone
- •mestatases or new/enlarging lymph node disease, consistent with
- •prostate cancer.
- •b. PSA progression defined by sequence of rising values separated by >
- •1 week (2 separate increasing values) over a threshold minimum of 2.0
- •ng/ml. (PCWG2 PSA eligibility criteria).
- •5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate
- •cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate
- •cancer is permissible if >3 years prior.
- •6. Vaccinia-experienced (previous smallpox vaccination).
- •7. ECOG Performance Score of 0 or 1.
- •8. Life expectancy = 1 year.
- •9. Bone Marrow function:
- •- Absolute neutrophil count = 1,500/mm3
- •- Hemoglobin = 10 g/dL
- •- Platelet count = 100,000/mm3
- •10. Hepatic Function:
- •- AST and ALT = 2.5 times upper limit of normal (ULN)
- •- Bilirubin = 1.5 times ULN
- •11. Renal Function:
- •- Creatinine = 2.0 times ULN
- •12. Currently using a GnRH agonist or antagonist (unless surgically
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
Exclusion Criteria
- •1. Cancer-related pain requiring scheduled opioid narcotics for control
- •(as needed. = 2x per week is allowed).
- •2. Metastasis to organ systems other than lymph nodes and/or bone.
- •3. LDH = 2 times ULN.
- •4. Alkaline phosphatase = 2 times ULN.
- •5. Estimated PSA doubling time of <1 month as established within 6
- •months of the anticipated first dose of vaccine or placebo. A minimum of
- •3 PSA level determinations, at least 2 weeks apart (over a 6 month timeperiod), are required for assessment.
- •6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for
- •prostate cancer
- •7. Receipt of an investigational agent within 30 days (or 60 days for an
- •antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
- •There is no exclusion to previous experimental therapy provided
- •dosing/treatment is completed at least 30 days prior to the first planned
- •dose of vaccine unless otherwise noted.
- •8. History of prior malignancies other than prostate cancer within the
- •past 3 years, excluding successfully resected basal or squamous cell
- •carcinoma of the skin
- •9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina,
- •ventricular or hemodynamically significant atrial arrhythmia, or
- •cardiovascular disease such as stroke or myocardial infarction (current
- •or within the past 6 months).
- •10. Confirmed positive for HIV, hepatitis B, and /or hepatitis C.
- •11. Prior solid organ or bone marrow transplant
- •12. Immunodeficiency or splenectomy
- •13. Chronic immunosuppressive therapy within 30 days of screening.
- •14. Inflammatory eye disease requiring steroid treatment.
- •15. Chronic administration (defined as daily or every other day for
- •continued use > 14 days) of systemic corticosteroids within 28 days of
- •the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal
- •sprays, and topical creams for small body areas is allowed.
- •16. History of or active autoimmune disease (e.g. autoimmune
- •neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus
- •erythematosis, Sjogren?s syndrome, scleroderma, myasthenia gravis,
- •Goodpasture?s syndrome, Addison?s disease, Hashimoto?s thyroiditis, or
- •Graves disease). Persons with vitiligo are not excluded. Diabetics are not
- •excluded if the condition is well controlled.
- •17. Known allergy to eggs, egg products, aminoglycoside antibiotics (for
- •example, gentamicin or tobramycin), or GM-CSF. Subjects with a known
- •or suspected allergy to radiological contrast agents are eligible, but this
- •must be noted in the subject's medical history and in the chart notes.
- •18. History of atopic dermatitis or active skin condition (acute, chronic,
- •exfoliative) that disrupts the epidermis.
- •19. Previous adverse reactions to smallpox vaccination.
- •20. Unable to avoid close contact or household contact with the
- •following high-risk individuals for three weeks after the Day 1
- •vaccination or until the vaccination site heals completely: (a) children =
- •3 years of age, (b) pregnant or nursing women, (c) individuals with prior
- •or concurrent extensive eczema or other eczemoid skin disorders, or (d)
- •immunocompromised individuals, such as those with HIV.
- +4 more not shown
Investigators
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