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

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ClinicalTrials.gov Identifier: NCT03579654
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
OncBioMune Pharmaceuticals

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 low-risk 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Proscavax Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 - Proscavax vaccine treatment
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
Proscavax is a prostate cancer vaccine which combines the prostate antigen PSA with immune stimulatory cytokines (IL-2 and GM-CSF).

No Intervention: Arm 2 - Active Surveillance
In this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.



Primary Outcome Measures :
  1. 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 Arm 1 and at study entry for Arm 2 ]
    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

  2. 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

  3. 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 Outcome Measures :
  1. PSA doubling time [ Time Frame: At pre-study, and then every 3 months till 2 years, starting at week 7 for Arm 1 and at study entry for Arm 2 ]
    Determine the rate of PSA level to double over time

  2. Assessment of Adverse Events [ Time Frame: From first injection until 30 days past the 24-month assessments ]
    Confirm safety and tolerability of Proscavax vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate.
  2. Age ≥ 18 years.
  3. 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).
  4. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  6. Patients must have the following laboratory values:

    1. Absolute neutrophil count (ANC) > 1500/µL
    2. Platelet count >100,000/µL
    3. Hemoglobin > 10 g/dL
    4. Bilirubin < 1.5 x upper limits of normal
    5. Aspartate aminotransferase (AST) < 1.5 x upper limits of normal
    6. Adequate estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2 (adjusted for race)
  7. Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
  8. Patient is accessible and compliant for follow-up.
  9. Prostate biopsy requirements:

    1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
    2. 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
  10. Must have < 4 cores with cancer and no Gleason pattern 4 disease; PSA less than 10 ng/mL; no palpable nodule (<T2a) and ≤50% tumor in any core.
  11. Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include:

    1. surgical sterilization (patient and/or patient's partner),
    2. approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot),
    3. barrier methods (such as a condom or diaphragm) used with a spermicide, and
    4. an intrauterine device (IUD).

Exclusion Criteria:

  1. Unwillingness or inability (such as coagulopathy) to undergo serial prostate biopsy.
  2. 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.
  3. Evidence of metastatic disease.
  4. 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.
  5. Inability to give consent.
  6. Any condition that, according to the investigator, would make the patient an inappropriate study candidate.
  7. 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.
  8. Patients with existing autoimmune disorders (IL-2 and GM-CSF carry risk of exacerbating underlying autoimmune disorders).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579654


Contacts
Contact: Rupal S Bhatt, MD, PhD (617) 735-2062 rbhatt@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215-5400
Contact: Rupal S Bhatt, MD, PhD         
Principal Investigator: Rupal S Bhatt, MD, PhD         
Sub-Investigator: Glen Bubley, MD         
Sub-Investigator: David Einstein, MD         
Sponsors and Collaborators
OncBioMune Pharmaceuticals
Investigators
Principal Investigator: Rupal Bhatt, MD, PhD Harvard Medical Faculty Physicians Practice

Responsible Party: OncBioMune Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03579654     History of Changes
Other Study ID Numbers: O17-11110
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by OncBioMune Pharmaceuticals:
Prostate Specific Antigen
Immunotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs