ProstAtak Immunotherapy for Prostate Cancer

Recruiting at 22 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Candel Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunosuppressives, 5-alpha-reductase inhibitors

Disqualifiers: Active liver disease, HIV, Metastatic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

187 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CAN-2409, a treatment that kills prostate cancer cells and boosts the immune system to fight the cancer. It targets patients with localized prostate cancer. The treatment aims to improve their health outcomes by helping their immune system attack the cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking 5-alpha-reductase inhibitors (like finasteride or dutasteride) and systemic corticosteroids (more than 10 mg of prednisone per day). If you are on these medications, you will need to discontinue them to participate.

What data supports the effectiveness of the treatment CAN-2409 Immunotherapy for prostate cancer?

While specific data on CAN-2409 is not provided, research shows that immunotherapy can enhance immune responses and slow tumor growth in prostate cancer. Combination strategies with other treatments have shown promise in improving outcomes. ^{1 2 3 4 5}

Is ProstAtak Immunotherapy generally safe for humans?

The safety data for similar immunotherapies, like peptide vaccinations and cancer cell vaccines, show they are generally well tolerated with no major adverse effects, mostly causing mild skin reactions at the injection site. ^{6 7 8 9 10}

How is the ProstAtak Immunotherapy treatment different from other prostate cancer treatments?

ProstAtak Immunotherapy, involving CAN-2409, is unique because it uses a gene therapy approach to stimulate the immune system to attack prostate cancer cells, unlike traditional treatments that may rely on surgery, radiation, or chemotherapy. This treatment aims to enhance the body's natural immune response specifically against cancer cells, offering a novel mechanism compared to existing therapies. ^{7 11 12 13 14}

Eligibility Criteria

Men with localized prostate cancer who choose active surveillance and meet certain risk criteria (low to intermediate, or one high-risk feature) can join. They must be able to undergo multiple injections into the prostate and have a performance status allowing daily activities. Excluded are those with advanced disease, other cancers, liver disease, HIV+, on immunosuppressants or planning radical treatment within a year.

Inclusion Criteria

My cancer is not classified as high risk, very high risk, or metastatic.

My prostate cancer diagnosis was confirmed through a tissue examination.

I have chosen to monitor my condition without immediate treatment.

Exclusion Criteria

My cancer has spread to lymph nodes or other parts of my body.

Known HIV+ patients

Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir or placebo + valacyclovir

8 weeks

Active Surveillance

Participants undergo standard of care active surveillance evaluations

Ongoing throughout the study

Follow-up

Participants are monitored for progression-free survival and other outcomes

Approximately 5 years

Treatment Details

Interventions

• CAN-2409 Immunotherapy

Trial Overview The trial is testing CAN-2409 immunotherapy which uses aglatimagene besadenovec to kill tumor cells and stimulate an immune response against cancer. Participants will either receive this therapy or a placebo in addition to standard active surveillance for prostate cancer at a ratio of 2:1.

Participant Groups

Group I: CAN-2409 Active Control 2 Interventions

Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir

Group II: Placebo Placebo Group 2 Interventions

Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir

Who Is Running the Clinical Trial?

Candel Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

1,300+

Findings from Research

The IMbassador250 trial involving 759 men with metastatic castration-resistant prostate cancer found that adding atezolizumab to enzalutamide did not improve overall survival, although it had an acceptable safety profile.

However, patients with high levels of PD-L1 expression and certain immune gene signatures showed longer progression-free survival, suggesting that careful patient selection could enhance the effectiveness of immune checkpoint inhibitors in this cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Powles, T., Yuen, KC., Gillessen, S., et al.[2023]

Immunotherapy, particularly with the FDA-approved sipuleucel-T, has emerged as a promising treatment option for metastatic castrate-resistant prostate cancer (CRPC), complementing traditional therapies like androgen deprivation and chemotherapy.

Current clinical trials are exploring various immunotherapy approaches, including cancer vaccines and immune checkpoint inhibitors, to enhance treatment effectiveness and potentially improve patient outcomes in CRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From bench to bedside: immunotherapy for prostate cancer. Tse, BW., Jovanovic, L., Nelson, CC., et al.[2021]

This systematic review analyzed 24 prostate cancer patients and found that immunotherapies, particularly IMM-101, showed promising results with a mean overall survival (OS) of 56 months, indicating potential benefits for patients.

Among the immunotherapies studied, Pembrolizumab and IMM-101 were the most commonly used, highlighting their relevance in the treatment landscape for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. Ashraf, MU., Farwa, U., Siddiqa, M., et al.[2023]

Immunotherapy is becoming a promising treatment option for prostate cancer, with ongoing phase III trials exploring various vaccine and immune-based therapies that enhance immune responses and slow tumor growth.

Current evidence suggests that patients with less aggressive forms of prostate cancer may benefit more from immunotherapies, and ongoing trials are investigating combinations of these therapies with traditional treatments to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Immunotherapies in Prostate Cancer. Strauss, J., Madan, RA.[2022]

Immunotherapy is emerging as a promising treatment for prostate cancer, which is traditionally treated with surgery, radiotherapy, and hormonal therapy, especially for advanced cases where docetaxel-based chemotherapy is FDA-approved and shows significant survival benefits.

Recent developments in prostate cancer immunotherapy, including dendritic cell vaccines and immune checkpoint inhibitors, have shown potential for targeted tumor destruction with less systemic toxicity, although these benefits are still being evaluated in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update: immunological strategies for prostate cancer. Drake, CG., Antonarakis, ES.[2021]

In a phase I study involving 10 patients with metastatic hormone-refractory prostate cancer, peptide vaccination was found to be safe and well tolerated, with no major adverse effects reported, although some patients experienced mild dermatologic reactions at the injection site.

The vaccination led to increased immune responses in some patients, with one patient showing a complete disappearance of a pelvic bone metastasis and three patients experiencing a decrease in serum PSA levels, suggesting potential efficacy and warranting further research into this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of patient-oriented vaccination in HLA-A2-positive patients with metastatic hormone-refractory prostate cancer. Noguchi, M., Itoh, K., Suekane, S., et al.[2020]

References

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

Immunotherapy of Prostate Cancer: Facts and Hopes. [2023]

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

Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. [2023]

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

From bench to bedside: immunotherapy for prostate cancer. [2021]

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

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. [2023]

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

Integrating Immunotherapies in Prostate Cancer. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Cellular immunotherapies for prostate cancer. [2007]

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

Immunotherapy of prostate cancer. [2023]

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

Update: immunological strategies for prostate cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Phase I trial of patient-oriented vaccination in HLA-A2-positive patients with metastatic hormone-refractory prostate cancer. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Allogeneic retrovirally transduced, IL-2- and IFN-gamma-secreting cancer cell vaccine in patients with hormone refractory prostate cancer--a phase I clinical trial. [2018]

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

Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer. [2020]

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

Granulocyte-macrophage colony-stimulating factor-transduced allogeneic cancer cellular immunotherapy: the GVAX vaccine for prostate cancer. [2021]

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

Granulocyte macrophage colony-stimulating factor--secreting allogeneic cellular immunotherapy for hormone-refractory prostate cancer. [2020]

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

Immunologic approaches to the treatment of prostate cancer. [2007]