CAMPAS: Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance

Sponsor

Omnitura Therapeutics, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03495479

Collaborator

Vancouver Prostate Centre (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: OMN54

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Phase IIA, Single-Center, Single-Arm Clinical Study of OMN54 (Aneustat) in Men Diagnosed With Prostate Cancer Being Followed by Active Surveillance

Anticipated Study Start Date :

Jan 1, 2025

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
OMN54 -Treated Six-month, daily oral dosing in softgel capsules throughout the first 6 months of treat.	Drug: OMN54 Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator. Other Names: Aneustat(TM)

Arm

Intervention/Treatment

OMN54 -Treated

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

Drug: OMN54

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

Other Names:

Aneustat(TM)

Outcome Measures

Primary Outcome Measures

Changes in Prostate Specific Antigen [12 months]
Quarterly assessment of serum Prostate Specific Antigen (PSA)
Changes in Tumor Size [12 months]
Changes in tumor size based on semi-annual MRI
Changes in Urinary Flow [12 months]
Quartelry assessment of patient urinary flow based on patient IPSS Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions
Platelet count ≥100,000 platelet/mm3 (100 x 109/L)
White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC) ≥1.5 x109/L

Adequate hepatobiliary function as demonstrated by:

Total bilirubin level within normal limits
Alanine aminotransferase (ALT) levels within normal limits
Adequate renal function as demonstrated by creatinine level within normal limits or creatinine clearance within normal limits
Coagulation profile (PT, PTT, INR and TCT) within normal limits

If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, partner use of diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of OMN54

Exclusion Criteria:

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: