What side effects are associated with this type of intervention?

Common treatments for prostate cancer that kill tumor cells and stimulate an immune response, such as immunotherapies and radiation therapy, can have a range of side effects. Immunotherapies like sipuleucel-T may cause fatigue, nausea, anemia, elevated transaminases, anorexia, rash, constipation, thrombocytopenia, vomiting, and diarrhea. Radiation therapy can lead to urinary symptoms, bowel issues, and erectile dysfunction. Combining these treatments, as in the case of ProstAtak, aims to enhance efficacy while maintaining a manageable side effect profile.

What prior FDA approvals exist?

Sipuleucel-T (Provenge) is an FDA-approved immunotherapy for metastatic castration-resistant prostate cancer (CRPC) that stimulates the immune system to target prostate cancer cells. Additionally, lutetium Lu 177 vipivotide tetraxetan is a radioligand therapy approved for PSMA-positive metastatic CRPC, which targets and kills cancer cells while potentially stimulating an immune response. These treatments are similar to ProstAtak, which aims to kill tumor cells and induce an immune response.

What other types of research exist?

Promising novel alternatives to ProstAtak for prostate cancer treatment include: 1) P-PSMA-101 CAR-T cells, which target PSMA on prostate cancer cells and have shown potential in early trials. 2) Immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 therapies, which have shown efficacy in various cancers and are being explored for prostate cancer. 3) Bipolar Androgen Therapy (BAT), which has shown potential in restoring sensitivity to other treatments and improving biochemical progression-free survival. These alternatives are in various stages of clinical trials and may offer new hope for prostate cancer patients in 2024.

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Cancer Vaccine

ProstAtak® Immunotherapy + Radiation for Prostate Cancer (PrTK03 Trial)

Phase 3

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

Planning to undergo standard prostate-only external beam radiation therapy

Be older than 18 years old

Must not have

Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs

Liver disease, including known cirrhosis or active hepatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.

Awards & highlights

Summary

This trial is testing whether adding ProstAtak immunotherapy to radiation therapy can improve outcomes for patients with localized prostate cancer at high or intermediate risk for the disease coming back.

Who is the study for?

Men with intermediate-high risk localized prostate cancer, who have a good performance status (able to carry out daily activities), and meet specific criteria like PSA levels or Gleason score. They shouldn't have low-risk or high-risk factors beyond one, no regional lymph node involvement or distant metastases, no prior prostate cancer treatments except for certain types, and can't be on immunosuppressive drugs.Check my eligibility

What is being tested?

The trial is testing ProstAtak® Immunotherapy combined with standard radiation therapy against a placebo plus radiation. Participants are randomly assigned in a 2:1 ratio to either the treatment group or control group. The goal is to see if ProstAtak® improves outcomes by stimulating the immune system to fight cancer cells.See study design

What are the potential side effects?

ProstAtak®, when used with radiation therapy, has previously shown synergy without added toxicity; however, potential side effects may include typical reactions related to immunotherapies such as flu-like symptoms, fatigue, skin reactions at injection sites and possible mild fever.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for radiation therapy targeting only my prostate.

Exclusion Criteria

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

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

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I have liver disease, such as cirrhosis or active hepatitis.

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

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I am scheduled for radiation therapy targeting my pelvic area.

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I have had or am planning to have surgery to remove my testicles for cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.

Secondary outcome measures

PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.

Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.

Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProstAtak®Experimental Treatment1 Intervention

Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT

Group II: ControlPlacebo Group1 Intervention

Placebo + valacyclovir + radiation therapy +/- ADT

0 / 6Eligibility 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), radiation therapy, and immunotherapy. ADT works by reducing androgen levels or blocking their effects, which slows the growth of prostate cancer cells that rely on these hormones. Radiation therapy uses high-energy rays to kill cancer cells or inhibit their growth. Immunotherapy, such as ProstAtak, not only kills tumor cells but also stimulates the immune system to recognize and destroy cancer cells. This dual action is particularly important as it can lead to a more robust and long-lasting anti-cancer response, potentially improving outcomes for prostate cancer patients.