Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance

NCT03495479 | Withdrawn

• 1 other identifier: OMN54-PC-02
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate cancer who are otherwise healthy and free of significant co-morbidities and have chosen active surveillance for disease management. The investigators will assess how OMN54 affects PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will be tested to follow disease evolution.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; PC; Active Surveillance; Chemonaiive; OMN54; Aneustat (TM); PSA; BPH

Outcome Measures

Primary Outcomes (3)

• Changes in Prostate Specific Antigen

  Quarterly assessment of serum Prostate Specific Antigen (PSA)

  12 months

• Changes in Tumor Size

  Changes in tumor size based on semi-annual MRI

  12 months

• Changes in Urinary Flow

  Quartelry assessment of patient urinary flow based on patient IPSS Questionnaire

  12 months

Study Arms (1)

OMN54 -Treated

Six-month, daily oral dosing in softgel capsules throughout the first 6 months of treat.

Drug: OMN54

Interventions

OMN54 DRUG

Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator.

Also known as: Aneustat(TM)

OMN54 -Treated

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men diagnosed with early stage prostate cancer that elect to pursue active surveillance for disease management and agree to take the study drug.

You may qualify if:

• \- Localized prostate cancer suitable for active surveillance
• Histologically confirmed adenocarcinoma of the prostate, with Gleason Score 6 or less prostate cancer. No limit in the percentage of cancer in each core or percentage of positive cores.
• Male, 18 years or older
• Able to swallow the soft gelatin capsule form of the drug which is \~6mm long.
• Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
• No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
• ECOG Performance Status 0 or 1.
• Patient has elected Active Surveillance as preferred management plan for prostate cancer.
• Written informed consent obtained prior to any patient participation.
• Participant is accessible and compliant for follow-up.
• Prostate biopsy requirements:
• If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
• If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.
• Voiding requirements: IPSS score of at least 15 and Qmax \< 15 cc/s.
• Adequate hematopoietic function as demonstrated by:

You may not qualify if:

• Unwillingness or inability to undergo serial prostate biopsy or MRI.
• History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years.
• Previous surgical intervention for BPH
• Active uncontrolled infection, including known history of HIV, hepatitis B or C
• Concurrent uncontrolled hypertension
• Congestive Heart Failure
• Hepatic disease (cirrhosis, hepatitis, hepatocellular carcinoma or liver failure of unknown etiology)
• Renal disease (glomerulonephritis, nephropathy, polycystic kidney disease)
• Patients requiring new treatment of BPH (either medical or surgical) are not eligible.
• Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
• Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54); soy; any of the plants belonging to the Ganodermataceae family, e.g., reishi mushroom (Ganoderma lucidum, lingzhi); any plants belonging to Labiatae or Lamiaceae families, e.g., culinary herbs including basil, mint, rosemary, sage, savory, marjoram, oregano, thyme, lavender, and perilla; or Aneustat™ (OMN54) excipients.
• Concurrent administration, or exposure within 30 days, of:
• Investigational drugs and devices
• Chemotherapy
• Radiation therapy

Sponsors & Collaborators

• Omnitura Therapeutics, Inc.: lead
• Vancouver Prostate Centre: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alan So, MD

  Prostate Centre at Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: April 12, 2018
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 18, 2021

Record last verified: 2021-10