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Cancer Vaccine
Proscavax for Prostate Cancer
Phase 2
Waitlist Available
Led By Rupal S Bhatt, MD, PhD
Research Sponsored by OncBioMune Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
Awards & highlights
Study Summary
Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate cancer progression measured by PSA test
Prostate cancer progression measured by digital rectal examination (DRE)
Prostate cancer progression measured by prostate Biopsy
Secondary outcome measures
Assessment of Adverse Events
PSA doubling time
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 - Proscavax vaccine treatmentExperimental Treatment1 Intervention
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.
Group II: Arm 2 - Active SurveillanceActive Control1 Intervention
In this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.
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Who is running the clinical trial?
OncBioMune PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Prostate Cancer
48 Patients Enrolled for Prostate Cancer
Rupal S Bhatt, MD, PhDPrincipal InvestigatorHarvard Medical Faculty Physicians Practice
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