Trial Summary
What is the purpose of this trial?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.
Do I need to stop taking my current medications for this trial?
You must stop taking strong inhibitors or inducers of CYP3A4 and CYP2C19 two weeks before and during the study. Also, discontinue any herbal supplements containing AGN extract, including CognI.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, and EstroG-100/Profemin, four weeks before starting the study. If you are on androgen deprivation therapy or taking Warfarin/Coumadin, you cannot participate in the trial.
What data supports the idea that AGN-CognI.Q for Prostate Cancer is an effective treatment?
The available research does not provide specific data on AGN-CognI.Q for Prostate Cancer. Instead, it focuses on other treatments like apalutamide, which has been shown to improve survival and quality of life in prostate cancer patients. Without direct evidence for AGN-CognI.Q, we can't conclude its effectiveness for prostate cancer based on the provided information.
12345What safety data exists for AGN-CognI.Q in prostate cancer treatment?
The provided research does not contain specific safety data for AGN-CognI.Q, Cogni-Q, or PQQ + CoQ10 in the treatment of prostate cancer. The studies focus on androgen deprivation therapy and its cognitive effects, but do not mention AGN-CognI.Q or related compounds.
26789Eligibility Criteria
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.Inclusion Criteria
I have low-risk prostate cancer and have not started or chosen to forgo treatment.
I am not currently on hormone therapy for cancer.
I have had prostate cancer before, but it wasn't neuroendocrine or small cell type.
+10 more
Exclusion Criteria
I am currently on hormone therapy for my cancer.
I do not have severe heart problems or recent heart attacks.
I am currently on chemotherapy, oral TKI, or immunotherapy.
+5 more
Participant Groups
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.
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)
AGN-CognI.Q is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as Cogni-Q for:
- Cognitive health
- Mitochondrial function
- Antioxidant support
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Cancer InstituteHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. [2021]In the SPARTAN trial, addition of apalutamide to androgen deprivation therapy, as compared with placebo plus androgen deprivation therapy, significantly improved metastasis-free survival in men with non-metastatic castration-resistant prostate cancer who were at high risk for development of metastases. We aimed to investigate the effects of apalutamide versus placebo added to androgen deprivation therapy on health-related quality of life (HRQOL).
Estradiol and cognition during androgen deprivation in men with prostate carcinoma. [2013]The adverse effects of hormonal manipulation in prostate carcinoma need to be established in view of its increasing use as an adjuvant treatment. This prospective study investigated the association of androgen deprivation-induced estradiol decline with cognition in prostate carcinoma.
Quality of life compared during pharmacological treatments and clinical monitoring for non-localized prostate cancer: a randomized controlled trial. [2013]To investigate the effects of different management strategies for non-localized prostate cancer on men's quality of life and cognitive functioning.
Blood Biomarker Landscape in Patients with High-risk Nonmetastatic Castration-Resistant Prostate Cancer Treated with Apalutamide and Androgen-Deprivation Therapy as They Progress to Metastatic Disease. [2022]In the placebo-controlled SPARTAN study, apalutamide added to androgen-deprivation therapy (ADT) improved metastasis-free survival, second progression-free survival (PFS2), and overall survival (OS) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). Mechanisms of resistance to apalutamide in nmCRPC require evaluation.
Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study. [2023]Whether disease burden in patients with metastatic castration-sensitive prostate cancer (mCSPC) predicts treatment outcomes is unknown. We assessed apalutamide treatment effect in TITAN patients with mCSPC by disease volume, metastasis number and timing of metastasis presentation.
A new compound targets the AF-1 of androgen receptor and decreases its activity and protein levels in prostate cancer cells. [2021]Increased expression levels of constitutively active androgen receptor splice variants (AR-Vs) cause alterations in AR signaling, resulting in drug resistance and failed hormone therapy among patients with advanced prostate cancers. Several available compounds targeting the androgen axis and AR signaling have not demonstrated efficacy in preventing prostate cancer recurrence. Here, we investigated whether a new agent, 6-[6-ethoxy-5-ispropoxy-3,4-dihydroisoquinolin-2[1H)-yl]-N-[6-methylpyridin-2-yl]nicotinamide (EIQPN), has the potential for treating advanced prostate cancer. EIQPN interacted with the AR-activation fragment-1 (AF-1) domain and blocked its androgen-independent activity, robustly decreased the protein levels of AR and variants in prostate cancer cells by inducing AR protein degradation, and inhibited the androgen-independent proliferation of various AR-positive prostate cancer cells. In xenograft mouse models, EIQPN blocked the tumor growth of androgen-independent prostate cancer cells. Overall, these findings indicate that EIQPN could serve as a novel therapeutic agent for advanced recurrent prostate cancers.
Cognitive Dysfunction in Patients Treated with Androgen Deprivation Therapy: A Multimodality Functional Imaging Study to Evaluate Neuroinflammation. [2023]Androgen deprivation therapy (ADT) for prostate cancer is implicated as a possible cause of cognitive impairment (CI). CI in dementia and Alzheimer's disease is associated with neuroinflammation. In this study, we investigated a potential role of neuroinflammation in ADT-related CI.
Androgen Deprivation Therapy and Future Alzheimer's Disease Risk. [2022]To test the association of androgen deprivation therapy (ADT) in the treatment of prostate cancer with subsequent Alzheimer's disease risk.
Androgen deprivation therapy and cognitive decline-associations with brain connectomes, endocrine status, and risk genotypes. [2022]Evidence suggests that prostate cancer (PC) patients undergoing androgen deprivation therapy (ADT) are at risk for cognitive decline (CD), but the underlying mechanisms are less clear. In the present study, changes in cognitive performance and structural brain connectomes in PC patients undergoing ADT were assessed, and associations of cognitive changes with endocrine status and risk genotypes were explored.
Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with minimally symptomatic metastatic castration-resistant prostate cancer. [2022]Tasquinimod (Active Biotech) is an oral immunomodulatory, anti-angiogenic, and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). Here, we report long-term survival with biomarker correlates from this trial.
Inhibition of metastasis in a castration resistant prostate cancer model by the quinoline-3-carboxamide tasquinimod (ABR-215050). [2017]Tasquinimod (ABR-215050) is an orally active quinoline-3-carboxamide analog that has completed phase II clinical trial in patients with castration resistant prostate cancer, showing promising inhibiting effects on the occurrence of metastasis and delayed disease progression. Its mechanism of action is not fully elucidated, but previous studies show anti-angiogenic effects and strong interaction with the S100A9 protein.
Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial. [2023]This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.
Identification of targets for prostate cancer immunotherapy. [2021]We performed profiling of the immune microenvironment of castration-resistant (CRPC) and castration-sensitive (CSPC) prostate cancer (PC) in order to identify novel targets for immunotherapy.
Transcriptional mediators of treatment resistance in lethal prostate cancer. [2023]Metastatic castration-resistant prostate cancer is typically lethal, exhibiting intrinsic or acquired resistance to second-generation androgen-targeting therapies and minimal response to immune checkpoint inhibitors1. Cellular programs driving resistance in both cancer and immune cells remain poorly understood. We present single-cell transcriptomes from 14 patients with advanced prostate cancer, spanning all common metastatic sites. Irrespective of treatment exposure, adenocarcinoma cells pervasively coexpressed multiple androgen receptor isoforms, including truncated isoforms hypothesized to mediate resistance to androgen-targeting therapies2,3. Resistance to enzalutamide was associated with cancer cell-intrinsic epithelial-mesenchymal transition and transforming growth factor-β signaling. Small cell carcinoma cells exhibited divergent expression programs driven by transcriptional regulators promoting lineage plasticity and HOXB5, HOXB6 and NR1D2 (refs. 4-6). Additionally, a subset of patients had high expression of dysfunction markers on cytotoxic CD8+ T cells undergoing clonal expansion following enzalutamide treatment. Collectively, the transcriptional characterization of cancer and immune cells from human metastatic castration-resistant prostate cancer provides a basis for the development of therapeutic approaches complementing androgen signaling inhibition.