What is the mechanism of action of this treatment?

Prostate cancer treatments primarily target the androgen receptor pathway, crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor signaling inhibitors, like enzalutamide, block androgen receptors, preventing cancer cell growth. Chemotherapy, such as docetaxel, kills rapidly dividing cancer cells. Immunotherapy, like sipuleucel-T, stimulates the immune system to attack cancer cells. Radiopharmaceuticals, such as radium-223, deliver targeted radiation to bone metastases, reducing tumor burden. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on cancer characteristics and patient health.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen receptor-targeted therapies (e.g., abiraterone, enzalutamide), immunotherapies (e.g., sipuleucel-T), radiopharmaceuticals (e.g., radium-223), and PARP inhibitors (e.g., olaparib, rucaparib), have various side effects. Androgen receptor-targeted therapies can cause hypertension, hypokalemia, and fatigue. Immunotherapies like sipuleucel-T are generally well-tolerated but may cause mild to moderate side effects such as chills, fever, and headache. Radiopharmaceuticals like radium-223 can lead to myelosuppression, nephrotoxicity, and salivary gland toxicity. PARP inhibitors often result in anemia, nausea, fatigue, and gastrointestinal issues. These side effects are typically manageable but should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide and abiraterone acetate are androgen receptor-targeted therapies that have shown efficacy in mCRPC patients. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has also been approved, demonstrating significant improvements in progression-free survival and overall survival. Additionally, radium-223 (Ra-223) is a bone-targeting radioisotope used in combination with other therapies to manage bone metastases in prostate cancer. These treatments focus on improving safety profiles and dose-response outcomes in advanced prostate cancer management.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment include the poly(ADP-ribose) polymerase inhibitor veliparib, which has shown a manageable safety profile and warrants further investigation. Additionally, Bipolar Androgen Therapy (BAT) has demonstrated potential in restoring sensitivity to abiraterone and enzalutamide in castration-resistant prostate cancer (CRPC) patients. These treatments are in various stages of clinical trials and offer new avenues for managing prostate cancer.

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AGN-CognI.Q for Prostate Cancer

Phase 1

Recruiting

Led By Monika Joshi, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Not on concurrent androgen deprivation therapy

History of prostate cancer diagnosis in the past. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded

Must not have

Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens

History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a herbal supplement from Angelica gigas Nakai root in prostate cancer patients with recurrent disease. The goal is to see how the body processes and reacts to the supplement, potentially delaying or avoiding further hormonal therapy. Angelica gigas Nakai root has been used in traditional medicine in Korea and has shown various bioactivities, including anticancer properties.

Who is the study for?

Men over 40 with prostate cancer, not on androgen deprivation therapy or having metastatic cancer. They must have stopped certain herbal supplements and strong CYP3A4/CYPC19 inhibitors/inducers for specific periods before the trial. Participants need normal liver/kidney function, acceptable blood counts, a life expectancy over 12 months, and agree to use effective contraception.

What is being tested?

The trial is testing AGN-CognI.Q's safety at different doses and how it affects the body (pharmacokinetics/pharmacodynamics) in men with prostate cancer. It aims to understand how the drug behaves after an acute dose and its potential effects on this patient group.

What are the potential side effects?

While specific side effects are not listed here, typical ones may include reactions at the site of administration, gastrointestinal issues like nausea or diarrhea, potential liver or kidney function changes, fatigue, allergic reactions or other immune-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am not currently on hormone therapy for cancer.

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I have had prostate cancer before, but it wasn't neuroendocrine or small cell type.

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I can take care of myself and am up and about more than half of the day.

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My liver, kidneys, and bone marrow are functioning well.

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I am a man aged 40 or older.

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I have stopped taking strong CYP3A4 and CYP2C19 inhibitors or inducers for 2 weeks before starting the study.

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I will stop taking supplements with AGN extract 4 weeks before starting the study drug.

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I am willing and able to give my consent for treatment.

Exclusion Criteria

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

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I am currently on hormone therapy for my cancer.

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I do not have severe heart problems or recent heart attacks.

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I am currently on chemotherapy, oral TKI, or immunotherapy.

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I am currently taking Warfarin or Coumadin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Electrocardiography (EKG) QTC Interval

Safety blood lab tests

Secondary study objectives

Peak Plasma Concentration (Cmax)

Plasma Concentration versus time curve (AUC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AGN-CognI.QExperimental Treatment1 Intervention

Dose level +1 (800 mg, 4 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 CognI.Q capsules, Fast at least 2 h before dose and 1 h after)

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

Prostate cancer treatments primarily target the androgen receptor pathway, crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor signaling inhibitors, like enzalutamide, block androgen receptors, preventing cancer cell growth. Chemotherapy, such as docetaxel, kills rapidly dividing cancer cells. Immunotherapy, like sipuleucel-T, stimulates the immune system to attack cancer cells. Radiopharmaceuticals, such as radium-223, deliver targeted radiation to bone metastases, reducing tumor burden. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on cancer characteristics and patient health.

Evidence Synthesis to Accelerate and Improve the Evaluation of Therapies for Metastatic Hormone-sensitive Prostate Cancer.