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Cancer Vaccine

Prostate Cancer Vaccine for Prostate Cancer

Phase 2
Waitlist Available
Led By James L. Gulley, MD, PhD, FACP
Research Sponsored by Kael-GemVax Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No immunocompromised status due to HIV positivity or active autoimmune diseases
No life-threatening illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is comparing a vaccine made from tumor cells to a placebo in treating patients with stage D0 prostate cancer.

Who is the study for?
Men with early-stage prostate cancer (Stage D0) who have a life expectancy of at least 6 months, normal organ and marrow function, no other active cancers in the last 5 years except certain skin or bladder cancers. They must not have serious illnesses that could affect treatment adherence, be HIV positive, or have severe autoimmune diseases.Check my eligibility
What is being tested?
This phase II trial is testing whether vaccines made from tumor cells are more effective than a placebo at stimulating the immune system to destroy prostate cancer cells. Patients will either receive the BCG vaccine, a new prostate cancer vaccine called ONY-P1, or a placebo.See study design
What are the potential side effects?
Possible side effects may include typical vaccine reactions like soreness at injection site, fever, fatigue. There's also potential for an allergic reaction to components of the vaccines and immune-related responses due to activation against body's own tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have HIV or active autoimmune diseases.
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I do not have any illnesses that could threaten my life.
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My prostate cancer has been confirmed by a biopsy.
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My prostate cancer diagnosis is confirmed by a pathologist, or my clinical signs match prostate cancer if no biopsy was done.
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I have no known allergies or adverse reactions to BCG vaccine.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to PSA progression
Secondary outcome measures
Immunologic response as assessed by ELISPOT assay
PSA kinetics (doubling time/velocity) of treatment
Time to testosterone recovery
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IExperimental Treatment2 Interventions
Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm IIPlacebo Group1 Intervention
Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCG vaccine
FDA approved

Find a Location

Who is running the clinical trial?

Kael-GemVax Co., Ltd.Lead Sponsor
2 Previous Clinical Trials
612 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,465 Total Patients Enrolled
562 Trials studying Prostate Cancer
507,282 Patients Enrolled for Prostate Cancer
James L. Gulley, MD, PhD, FACPPrincipal InvestigatorNational Cancer Institute (NCI)

Media Library

BCG vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00514072 — Phase 2
Prostate Cancer Research Study Groups: Arm II, Arm I
Prostate Cancer Clinical Trial 2023: BCG vaccine Highlights & Side Effects. Trial Name: NCT00514072 — Phase 2
BCG vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00514072 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research projects have been conducted utilizing the prostate cancer vaccine ONY-P1?

"Currently, 21 studies for prostate cancer vaccine ONY-P1 are still active with 7 trials in Phase 3. Locations hosting these research projects span across 61 cities, though the majority of sites are located in Nashville, Tennessee."

Answered by AI

What therapeutic use does the prostate cancer vaccine ONY-P1 have?

"ONY-P1, a prostate cancer vaccine, can be implemented as treatment for tuberculosis (tb), urothelial carcinoma recurrent and carcinoma in situ of urinary bladder."

Answered by AI

What safety data is available regarding the ONY-P1 prostate cancer vaccine?

"The safety of the ONY-P1 prostate cancer vaccine was evaluated as a 2 on our scale, signifying that there is evidence supporting its security but no proof for efficacy yet."

Answered by AI

Is there still an opportunity to volunteer for this research project?

"Unfortunately, this specific study is not accepting participants currently. It was first posted in March 2007 and its most recent update occured on August 8th 2012. Should you be searching for other studies related to prostate cancer, 1315 trials are actively recruiting as well as 21 that focus specifically on the ONY-P1 vaccine."

Answered by AI

What is the highest number of participants in this clinical research?

"This clinical trial is now closed. It was initially posted in March 2007 and its last update was on August 8th 2012. If you're searching for other studies, there are currently 1315 active trials related to prostate cancer, as well as 21 specific trials pertaining to the ONY-P1 vaccine."

Answered by AI

Has a research effort of this nature been undertaken previously?

"Kael-GemVax Co., Ltd. first introduced their prostate cancer vaccine ONY-P1 to the world in a clinical trial of 54 participants in 2007 and has since conducted 2737 studies extending its reach into 14 countries with 26 cities hosting live trials today."

Answered by AI
Recent research and studies
Frontiers in BioscienceJournal
Impact of Androgen-deprivation Therapy on the Immune System: Implications for Combination Therapy of Prostate Cancer
Aragon-Ching, Jeanny, B.. 2007. “Impact of Androgen-deprivation Therapy on the Immune System: Implications for Combination Therapy of Prostate Cancer”. Frontiers in Bioscience. IMR Press. doi:10.2741/2441.
BloodJournal
Elevated Serum Soluble CD40 Ligand in Cancer Patients May Play an Immunosuppressive Role
Huang, Jianping, Caroline Jochems, Tara Talaie, Austin Anderson, Alessandra Jales, Kwong Y. Tsang, Ravi A. Madan, James L. Gulley, and Jeffrey Schlom. 2012. “Elevated Serum Soluble CD40 Ligand in Cancer Patients May Play an Immunosuppressive Role”. Blood. American Society of Hematology. doi:10.1182/blood-2012-05-427799.
clinicaltrials.govStudy
Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer
2007. "Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00514072.
All > Prostate > Recurrent Prostate Cancer
~3 spots leftby May 2025
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