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

NCT03579654 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: O17-11110
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Prostate Specific Antigen; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• Prostate cancer progression measured by PSA test

  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

  At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms

• Prostate cancer progression measured by digital rectal examination (DRE)

  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

  At pre-study and then every 6-months for 2 years

• Prostate cancer progression measured by prostate Biopsy

  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

  At pre-study and then every 12-months for 2 years

Secondary Outcomes (2)

• PSA doubling time

  At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms

• Assessment of Adverse Events

  From first injection until 30 days past the 24-month assessments

Study Arms (2)

Arm 1 - Proscavax vaccine treatment

EXPERIMENTAL

In this arm, during the first 4 months of induction treatment, 6 doses of the Proscavax 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.

Biological: Proscavax

Arm 2 - Active Surveillance

NO INTERVENTION

In this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.

Interventions

Proscavax BIOLOGICAL

Proscavax is a prostate cancer vaccine which combines the prostate antigen PSA with immune stimulatory cytokines (IL-2 and GM-CSF).

Arm 1 - Proscavax vaccine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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).

Sponsors & Collaborators

• OncBioMune Pharmaceuticals: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5400, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rupal S Bhatt, MD, PhD

  Harvard Medical Faculty Physicians Practice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupal S Bhatt, MD, PhD

CONTACT

(617) 735-2062; rbhatt@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 6, 2018
• Study Start: February 28, 2019
• Primary Completion: February 28, 2021
• Study Completion: June 30, 2022
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (2)