ProstAtak Immunotherapy for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new immunotherapy treatment called CAN-2409 for individuals with localized prostate cancer under active surveillance. The treatment aims to kill cancer cells and enhance the immune system's ability to fight the cancer. Participants will receive either the CAN-2409 treatment or a placebo, alongside standard care. Men with prostate cancer who have chosen active monitoring and meet specific risk criteria may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in prostate cancer treatment.

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.

Is there any evidence suggesting that CAN-2409 immunotherapy is likely to be safe for humans?

Research has shown that CAN-2409 immunotherapy was well-tolerated in past trials for prostate cancer and other tumors. In these studies, patients responded positively without severe side effects. This suggests the treatment is generally safe. Additionally, CAN-2409 demonstrated promising results in aiding prostate cancer patients, supporting its potential as a safe treatment option. While individual experiences may vary, existing evidence reassures about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, CAN-2409 immunotherapy offers a novel approach. This treatment is unique because it utilizes a genetically modified virus, aglatimagene besadenovec, to stimulate the body's immune system to attack cancer cells specifically. Researchers are excited about CAN-2409 because it introduces a new mechanism of action that potentially increases the precision and effectiveness of targeting cancer cells while sparing healthy tissue. This could lead to fewer side effects compared to traditional therapies and represents a promising advancement in personalized cancer treatment.

What evidence suggests that CAN-2409 immunotherapy might be an effective treatment for prostate cancer?

Studies have shown that CAN-2409 immunotherapy can be effective for prostate cancer. In earlier trials, patients who received CAN-2409 lived longer without their cancer worsening, demonstrating a 38% improvement in outcomes related to prostate cancer. In this trial, participants randomized to the active arm will receive CAN-2409, which kills cancer cells and helps the immune system find and destroy them. These results suggest that CAN-2409 could improve health outcomes for people with localized prostate cancer. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. ir.candeltx.com ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-phase-3-clinical-trial-can-2409

Candel Therapeutics Presents Phase 3 Clinical Trial of ... CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated ...

2. ir.candeltx.com ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-positive-phase-3-can-2409-results

Candel Therapeutics Presents Positive Phase 3 CAN-2409 ... The Company's phase 3 clinical trial met its primary endpoint and secondary endpoints and demonstrated statistically significant improvement in DFS.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02768363

NCT02768363 | Randomized Controlled Trial of CAN-2409 ... The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer.

4. renalandurologynews.com renalandurologynews.com/news/urology/prostate-cancer/prostate-cancer-can-2409-immunotherapy-efficacy-treatment-risk/

CAN-2409 Immunotherapy Shows Efficacy for Intermediate ... Patients who received CAN-2409 had a significant 38% prolonged prostate cancer-specific DFS (HR, 0.62; 95% CI, 0.44-0.87; P =.0046). A higher ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT01436968

Phase 3 Study of ProstAtak® Immunotherapy With ... "CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046). Effects observed in both moderate hypofractionated EBRT (HR 0.52, CI ...

6. onclive.com onclive.com/view/can-2409-improves-dfs-in-intermediate-high-risk-localized-prostate-cancer

CAN-2409 Improves DFS in Intermediate/High-Risk ... CAN-2409 combined with valacyclovir and radiation therapy significantly improved DFS in prostate cancer patients, reducing recurrence or death ...