Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

Status unconfirmed · Phase 2

Conditions studied: Prostate Cancer

In brief

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

Key facts

Study ID

NCT03579654

Run by

OncBioMune Pharmaceuticals

People needed

120

Starts

2019-02-28

Expected to finish

2022-06-30

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate.
• Age ≥ 18 years.
• Clinically localized prostate cancer:
• T1 (Cancer can only be seen under a microscope),
• NX (Regional lymph nodes cannot be assessed) or N0 (Cancer cannot be seen in the lymph nodes),
• MX (Presence of distant metastasis cannot be assessed) or M0 (Cancer hasn't spread to other parts of the body).
• No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Patients must have the following laboratory values:
• Absolute neutrophil count (ANC) > 1500/µL
• Platelet count >100,000/µL
• Hemoglobin > 10 g/dL
• Bilirubin < 1.5 x upper limits of normal
• Aspartate aminotransferase (AST) < 1.5 x upper limits of normal
• Adequate estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2 (adjusted for race)
• Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
• Patient is accessible and compliant for follow-up.
• Prostate biopsy requirements:
• If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
• If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit. Patients must have been diagnosed with prostate cancer within 2 years of randomization (no history of prostate adenocarcinoma in any biopsies taken more than 2 years prior to randomization).
• Must have NCCN low or favorable-intermediate risk prostate cancer defined as:
• <50% of cores involved with cancer for eligibility and 50% or greater of cores involved with cancer progression. Only cores from standard TRUS biopsy (not MRI-guided cores) will be counted towards the number of cores involved.
• No primary Gleason pattern 4 (Gleason score 4+3) disease in any cores (TRUS or MRI-guided)
• PSA less than 20 ng/mL
• No extracapsular extension (<T3)

You may not qualify if…

• Unwillingness or inability (such as coagulopathy) to undergo serial prostate biopsy.
• History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.
• Evidence of metastatic prostate cancer.
• Immune-compromised patients including but not limited to: systemic immune suppressive medications within 6 weeks of enrolling; HIV-positive and below normal cluster of differentiation 4 (CD4) lymphocytes (less than 500 cells per microliter). Patients must be tested for HIV seropositivity and CD4 lymphocyte count to be eligible for the study.
• Inability to give consent.
• Any condition that, according to the investigator, would make the patient an inappropriate study candidate.
• Patients with significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class II and IV definitions, history of myocardial infarction within 6 months of study entry, uncontrolled dysrhythmias.
• Patients with existing autoimmune disorders (IL-2 and GM-CSF carry risk of exacerbating underlying autoimmune disorders).

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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