Adenovirus/PSA Vaccine for Prostate Cancer

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaccine designed to enhance the body's immune response against prostate cancer cells remaining after local treatments like surgery or radiation. Participants are divided into two groups: one receives only the vaccine, while the other receives both the vaccine and androgen deprivation therapy, a hormone therapy that lowers male hormone levels. Men whose prostate cancer has returned after surgery or radiation, and who show no signs of the cancer spreading, might be suitable candidates for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Adenovirus/PSA Vaccine is safe for people. In earlier studies, patients experienced no serious side effects from the vaccine. Most participants had a positive immune response, meaning their bodies recognized and reacted well to it.

When combined with androgen deprivation therapy (ADT), which lowers male hormone levels to slow cancer growth, no new safety issues have emerged. Overall, the vaccine has been well-tolerated. These findings suggest that the treatment is generally safe for those considering participation in this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Adenovirus/PSA Vaccine because it represents a novel approach to treating recurrent prostate cancer. Unlike traditional treatments like surgery, radiation, and hormone therapy, this vaccine uses a virus to deliver a piece of the prostate-specific antigen (PSA) to the immune system, effectively training it to recognize and attack cancer cells. This mechanism of action is particularly promising as it could lead to a targeted immune response against cancer, potentially reducing the risk of recurrence. Additionally, when combined with androgen deprivation therapy (ADT), there's hope that the vaccine might enhance the effectiveness of standard hormone treatments, offering a new avenue for managing the disease.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that the Adenovirus/PSA vaccine can activate strong immune responses in men with recurring prostate cancer. In earlier studies, 77% of patients experienced an increase in T cells that help the body identify and attack cancer cells. Another study found that 68% of patients had a positive T-cell response, and 34% developed antibodies against PSA, a protein associated with prostate cancer. In this trial, participants in one arm will receive the Adenovirus/PSA vaccine alone, while those in another arm will receive the vaccine combined with androgen deprivation therapy (ADT), which lowers male hormone levels that help cancer grow. The vaccine maintained these strong immune responses when used with ADT. These findings suggest that the vaccine, whether used alone or with ADT, may effectively help fight prostate cancer by boosting the body's immune system. ^{1 2 5 6 7}

Who Is on the Research Team?

David M Lubaroff, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Adenovirus/PSA Vaccine

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2787649/

Phase I Clinical Trial of an Adenovirus/PSA Vaccine for ... The majority of vaccinated patients produced anti-PSA T cell responses and over half survived longer than predicted by nomogram. Although the latter data are ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT00583024/Prot_SAP_000.pdf

phase ii study of adenovirus/psa vaccine in men with Such active immunization against prostate-cancer associated antigens might be more effective than active non-specific or adoptive/passive immunotherapy.

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2010.28.15_suppl.e15070

Adenovirus-PSA vaccination in recurrent and castration ... Preliminary results show that 77% of the patients in both protocols demonstrated anti-PSA T cell responses (by Ellispot) above preinjection levels and 72% of ...

4. immunitybio.com immunitybio.com/immunitybio-announces-12-month-overall-survival-probability-of-83-in-nci-led-phase-1-study-of-multi-targeted-had5-immunotherapy-vaccine-in-patients-with-advanced-metastatic-prostate-cancer/

ImmunityBio Announces 12-Month Overall Survival ... 12-Month Overall Survival Probability of 83% in NCI-Led Phase 1 Study of Multi-Targeted hAd5 Immunotherapy Vaccine in Patients with Advanced ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-09-1910/351564/p/Phase-I-Clinical-Trial-of-an-Adenovirus-Prostate

Phase I Clinical Trial of an Adenovirus/Prostate-Specific ... Anti-PSA antibodies were produced by 34% of patients and anti-PSA T-cell responses were produced by 68%. PSA doubling time was increased in 48%, whereas 55% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19920098/

Phase I clinical trial of an adenovirus/prostate-specific ... Conclusions: The adenovirus/PSA vaccine was proven safe with no serious vaccine-related adverse events. The majority of vaccinated patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00583752

Phase II Study of Adenovirus/PSA Vaccine in Men With ... Based upon our earlier clinical trial, the vaccine is considered safe and should not induce any major side effects. The investigators hope that vaccination with ...