Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21

(APP21 Trial)

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: David M Lubaroff

Must not be taking: Immunosuppressants, Prednisone, Hormonal therapy, others

Disqualifiers: Infection, CNS metastases, Immune compromise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or certain hormone therapies for prostate cancer, you may need to stop them as they are not allowed in the study.

What data supports the effectiveness of the Adenovirus/PSA Vaccine treatment?

Research shows that the Adenovirus/PSA Vaccine can trigger strong immune responses that help destroy prostate cancer cells in mice. Early results from human trials indicate that the vaccine is safe and can increase the time it takes for prostate cancer markers to rise, suggesting it may slow the progression of the disease. ^{1 2 3 4 5}

Is the Adenovirus/PSA Vaccine safe for humans?

The Adenovirus/PSA Vaccine has been tested in a phase I clinical trial for prostate cancer and was found to be safe even at the highest dose allowed by the FDA. Additionally, a similar adenovirus vaccine used in military recruits showed no significant increase in risk for most medical events, although rare occurrences of psoriasis and serum reactions were noted, but a direct link to the vaccine was not established. ^{1 2 3 6 7}

How is the Adenovirus/PSA Vaccine treatment different from other prostate cancer treatments?

The Adenovirus/PSA Vaccine is unique because it uses a virus to stimulate the immune system to specifically target and destroy prostate cancer cells that produce PSA (a protein made by the prostate). This approach is different from traditional treatments as it aims to harness the body's own immune response to fight the cancer, potentially offering a more targeted and less invasive option. ^{1 2 3 4 8}

Research Team

David M Lubaroff, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

Inclusion Criteria

Men with prostate cancer who have received prior local therapy (radical prostatectomy or definitive radiation therapy) and have biochemical (PSA) relapse without evidence of radiographic or clinical metastatic disease.

For men who had prior prostatectomy, the surgery must have occurred at least 6 months prior to initiation of treatment.

For men who had prior definitive radiation therapy, radiation must have been completed at least 1 year prior to initiation of treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy (ADT)

Subjects in Arm B will be started on androgen deprivation therapy 14 days prior to beginning the vaccinations

2 weeks

Vaccination

Subjects will be vaccinated three times, each injection administered at 30-day intervals

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

• Adenovirus/PSA Vaccine

Participant Groups

Group I: Androgen deprivation therapy (ADT) + Adenovirus/PSA Vaccine Experimental Treatment 1 Intervention

On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.

Group II: Adenovirus/PSA Vaccine Experimental Treatment 1 Intervention

On Arm A, subjects can begin the three vaccinations immediately.

Who Is Running the Clinical Trial?

David M Lubaroff

Lead Sponsor

Trials

2

Recruited

80+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Vaccine immunotherapy for prostate cancer: from mice to men. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of an adenovirus/prostate-specific antigen vaccine for prostate cancer: safety and immunologic results. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Immunization with type 5 adenovirus recombinant for a tumor antigen in combination with recombinant canarypox virus (ALVAC) cytokine gene delivery induces destruction of established prostate tumors. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Decreased cytotoxic T cell activity generated by co-administration of PSA vaccine and CpG ODN is associated with increased tumor protection in a mouse model of prostate cancer. [2006]

5. Netherlands pubmed.ncbi.nlm.nih.gov

CpG oligonucleotide as an adjuvant for the treatment of prostate cancer. [2009]

6. England pubmed.ncbi.nlm.nih.gov

A phase I trial of adenovector-mediated delivery of interleukin-2 (AdIL-2) in high-risk localized prostate cancer. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety evaluation of adenovirus type 4 and type 7 vaccine live, oral in military recruits. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Formulation of the bivalent prostate cancer vaccine with surgifoam elicits antigen-specific effector T cells in PSA-transgenic mice. [2018]