Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
With
National Cancer Institute (NCI)
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histopathologic documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study
Newly diagnosed or previously untreated prostate cancer with intermediate or high risk features as defined in the protocol
No evidence of metastatic disease on computed tomography (CT) / magnetic resonance imaging (MRI) or bone scans
No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous contrast, allergic reaction or anaphylaxis (in subjects who have known contrast allergies) are allowed
Eastern Co-operative Oncology Group (ECOG) performance status of 0-1
Human leukocyte antigen (HLA)-A2 or A3 positive for immunologic monitoring
Hematological and biochemical eligibility parameters as defined in the protocol
No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder)
Willing to travel to the study center(s) for follow-up visits
Age greater than or equal to 18 years old
Able to understand and sign informed consent
Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last administration of immunotherapy
You may not be if
No evidence of being immunocompromised by human immunodeficiency virus, a medical condition requiring systemic steroids, a medical condition requiring immunosuppressive therapy, splenectomy
Active Hepatitis B or Hepatitis C
Subjects should have no autoimmune diseases that have required treatment as specified in the protocol
History of immunodeficiency diseases, hereditary or congenital immunodeficiencies
Serious intercurrent medical illness
A clinically significant cardiac disease
Subjects who have received any prior therapy for prostate cancer
Subjects who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis
Subjects receiving any other investigational agents
Contraindication to biopsy such as bleeding disorders, ratio of prothrombin time to partial thromboplastin time (PT/PTT) \>=1.5 times the upper limit of normal, artificial heart valve
Contraindication to MRI such as subjects weighing \>136 kilograms, allergy to magnetic resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
Contraindication to radiation therapy such as pre-existing and active prostatitis or proctitis, inflammatory bowel disease or known genetic sensitivity to ionizing radiation, or history of prior radiation to the pelvis
Clareo Health | Tecemotide (L-BLP25) in Prostate Cancer
