Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance
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ClinicalTrials.gov Identifier: NCT03579654 |
Recruitment Status : Unknown
Verified March 2019 by OncBioMune Pharmaceuticals.
Recruitment status was: Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : March 6, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | June 6, 2018 | ||||
First Posted Date ICMJE | July 6, 2018 | ||||
Last Update Posted Date | March 6, 2019 | ||||
Estimated Study Start Date ICMJE | February 28, 2019 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance | ||||
Official Title ICMJE | 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 | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Biological: Proscavax
Proscavax is a prostate cancer vaccine which combines the prostate antigen PSA with immune stimulatory cytokines (IL-2 and GM-CSF).
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03579654 | ||||
Other Study ID Numbers ICMJE | O17-11110 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | OncBioMune Pharmaceuticals | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | OncBioMune Pharmaceuticals | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | OncBioMune Pharmaceuticals | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |