A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naive Patients With Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- OncBioMune Pharmaceuticals
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Prostate cancer progression measured by PSA test
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
This study will have 2 arms and patients will be randomized 2:1 into the Proscavax treatment arm (Arm 1) versus the active surveillance arm (Arm 2). In study Arm 1, 6 doses of the vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months. In study Arm 2, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Patients must have the following laboratory values:
- •Absolute neutrophil count (ANC) \> 1500/µL
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Prostate cancer progression measured by PSA test
Time Frame: At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by measuring change in PSA levels in patients in both arms
Prostate cancer progression measured by digital rectal examination (DRE)
Time Frame: At pre-study and then every 6-months for 2 years
Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by performing digital rectal examination (DRE) on patients in both arms
Prostate cancer progression measured by prostate Biopsy
Time Frame: At pre-study and then every 12-months for 2 years
Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by performing prostate biopsy on patients in both arms
Secondary Outcomes
- Assessment of Adverse Events(From first injection until 30 days past the 24-month assessments)
- PSA doubling time(At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms)