What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including immunotherapy like CAN-2409, often have side effects such as fatigue, nausea, and anorexia. Immunotherapies can also cause immune-related adverse events, including inflammation of organs like the liver, lungs, and intestines. Other advanced treatments, such as androgen receptor signaling inhibitors (e.g., enzalutamide) and radioligand therapies (e.g., lutetium Lu 177 vipivotide tetraxetan), may lead to side effects like bone marrow suppression, dry mouth, and increased risk of fractures. Traditional treatments like chemotherapy (e.g., docetaxel) can cause febrile neutropenia and other hematologic toxicities.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer that involve killing tumor cells and stimulating an immune response include sipuleucel-T (Provenge), an autologous cellular immunotherapy that stimulates an immune response against prostate cancer cells. Additionally, pembrolizumab (Keytruda), an immune checkpoint inhibitor, has been approved for metastatic castration-resistant prostate cancer (mCRPC) with specific genetic markers. Other treatments like enzalutamide (Xtandi) and abiraterone (Zytiga) target androgen receptor signaling to inhibit tumor growth. These therapies represent a range of approaches from direct tumor cell killing to immune system activation.

What other types of research exist?

Promising novel alternatives to CAN-2409 for prostate cancer patients include lutetium Lu 177 vipivotide tetraxetan, which has shown significant improvement in overall survival and progression-free survival in patients with PSMA-avid metastatic castration-resistant prostate cancer. Additionally, ongoing trials of immune checkpoint inhibitors and combinations with anti-VEGF/VEGFR agents are also showing potential.

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Cancer Vaccine

ProstAtak Immunotherapy for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Candel Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1

Histologically confirmed adenocarcinoma of the prostate

Must not have

Regional lymph node involvement or distant metastases

Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study completion, approximately 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

CAN-2409 has been well tolerated in past trials but may cause reactions related to the immune system's activation such as flu-like symptoms, injection site pain, and potentially mild fever. The exact side effects in this trial will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My prostate cancer is low risk with PSA under 10, Gleason score 6 or less, and is stage T1-T2a.

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I can take care of myself and perform daily activities.

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I am prepared and can safely undergo several prostate ultrasound injections.

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I am prepared and can safely undergo several prostate ultrasound injections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently taking medication for prostate enlargement or hair loss.

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I have used, am using, or plan to use hormone therapy for cancer or have had my testicles removed.

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I am taking more than 10 mg of prednisone daily or other drugs that weaken my immune system.

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I do not have any other cancer except for skin cancer.

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I have an active liver condition such as cirrhosis or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study completion, approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study completion, approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion, approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CAN-2409Active Control2 Interventions

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

Group II: PlaceboPlacebo Group2 Interventions

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and immunotherapy. ADT works by lowering testosterone levels to slow cancer growth, while chemotherapy uses drugs like docetaxel to kill rapidly dividing cancer cells. Immunotherapy, such as the use of aglatimagene besadenovec (CAN-2409), kills tumor cells and stimulates the immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific cancer type, potentially improving outcomes and minimizing side effects.

Targeting molecular resistance in castration-resistant prostate cancer.