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Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Hormonal Refractory Prostate Cancer

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Trial Information

Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or
recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been
facilitated by the identification of a number of prostate specific antigens that are
expressed in healthy and tumor prostate tissues. For prostatectomized patients, such
antigens offer ideal targets for immunotherapy as they are only present in tumor but not in
healthy tissue. The use of prostate specific antigens in a cancer vaccine is one attractive
option for cancer immunotherapy.

Inclusion Criteria:

- Signed informed consent in accordance with GCP and local regulatory requirements
prior to trial participation

- Male and age ≥ 18 years (Phase I and II) and ≤ 75 years (Phase II only)

- Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score

- Patients must have been treated with hormonal therapy and may have been treated with
surgery and/ or radiation therapy

- Progressive disease as defined by hormone-refractoriness and rise in PSA:

Hormone-refractoriness: Defined by a rise in PSA and/or RECIST-based progression of
evaluable lesions, and/or increased number of hotspots on a bone scan, while the patient
has a castrated level of testosterone. This castrated level may have been obtained by
orchiectomy, or LH-RH analog ± antiandrogen. Antiandrogen must be discontinued for at
least 4 weeks before study entry to exclude a withdrawal effect.

Rise in PSA: Defined by a rise in PSA levels at three consecutive time points (PSA rise
over nadir, separated by > 1 week, PCWG2 criteria)

- Presence of metastatic disease is acceptable

- ECOG performance status of 0 to 1

- Life expectancy > 12 months as assessed by the investigator

- Adequate organ function :

Bone marrow function: Hemoglobin ≥ 10 g/dL; Leukocytes ≥ 3000/µL; Lymphocytes ≥ 1000/µL;
Absolute neutrophil count ≥ 1500/µL; Platelet count ≥ 100000/µL Hepatic: AST and ALT ≤ 2.5
times upper limit of normal (ULN); Bilirubin ≤ 1.5 ULN Renal: Creatinine ≤ 1.5 mg/dL or
creatinine clearance ≥ 60mL/min

- Concomitant LH-RH therapy continuation is acceptable

- May have had local palliative radiotherapy for bone metastasis involving less than
25% of bone marrow

- Patients requiring bisphosphonates at the time of registration into the trial are
eligible (therapy initiated at least 28 days prior to first study treatment
administration) and must be continued at a constant level during the study period.

- Patients of child-producing potential must agree to use contraception while enrolled
in the study and for one month after the last immunization.

Exclusion Criteria:

- Other histologic type of prostate cancer (transitional cell, small cell or squamous
cell cancer)

- Symptomatic brain metastasis or leptomeningeal involvement

- Patients having received or currently receiving chemo- or biological therapy for
prostate cancer

- Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris;
significant cardiac arrhythmia

- Pulmonary disease causing dyspnea or fatigue during normal activity

- History of seizures, encephalitis or multiple sclerosis

- Inflammatory bowel disease e.g. Crohn's disease or ulcerative colitis; active

- Documented history of active autoimmune disorders requiring systemic
immunosuppressive therapy, (e.g. sarcoidosis, lupus erythematosus, rheumatoid
arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune
thyroiditis with only thyroid hormone replacement and stable disease > 1 year

- Primary or secondary immune deficiency

- History of allergy requiring medication

- Active drug abuse or chronic alcoholism

- Clinically significant active infections

- Seropositive for HIV, HBV or HCV

- History of other malignancies over the last 5 years (except basal cell carcinoma of
the skin)

- Uncontrolled medical condition considered as high risk for the treatment with an
investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known
ascites and/or pleural effusion, symptomatic pleural effusion treated by puncture

- Renal insufficiency requiring dialysis

- Patients being committed to an institution by virtue of an order issued either by the
judicial or the administrative authorities

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the recommended dose for exploration in the phase II part

Outcome Time Frame:

6-9 months

Safety Issue:


Principal Investigator

Kurt Miller, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

PMID: 19143027


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Hormonal Refractory Prostate Cancer
  • Hormonal refractory prostate cancer
  • RNA vaccine
  • Prostatic Neoplasms