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Prostate CancerPhase 2NCT03579654

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

A Phase 2 study testing Proscavax in people with Prostate Cancer, run by OncBioMune Pharmaceuticals at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Proscavax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
28 Feb 2019to 30 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

Rupal S Bhatt, MD, PhD contact

(617) 735-2062

rbhatt@bidmc.harvard.edu

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400

    Rupal S Bhatt, MD, PhD

    Rupal S Bhatt, MD, PhD

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Lauren Harshman, MD

    Lauren Harshman, MD

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Proscavax
Keywords
Prostate Specific Antigen, Immunotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProscavaxBiological

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

Study groups in NCT03579654
Study groupRoleWhat they receive
Arm 1 - Proscavax vaccine treatmentExperimentalIn 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.
Receives: Biological: Proscavax
Arm 2 - Active SurveillanceNo interventionIn this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes (2)

  1. PSA doubling time

    Determine the time for the PSA level to double

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

  2. Assessment of Adverse Events

    Confirm safety and tolerability of Proscavax vaccine

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start28 Feb 2019 (estimated)
  3. Primary completion28 Feb 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579654
Sponsor's protocol ID
O17-11110
Status last verified
Mar 2019
First submitted
6 Jun 2018
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proscavax in people with Prostate Cancer, run by OncBioMune Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rupal S Bhatt, MD, PhD ((617) 735-2062, rbhatt@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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