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Prostate CancerCAMPASNCT03495479

Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance

An observational study of Prostate Cancer, run by Omnitura Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 72 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
OMN54
Type of treatment
Pill or oral medicine
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2025to Jan 2029
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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
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  • 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
  • Immunotherapy

About this study

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

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
Being tested
OMN54
Keywords
Prostate Cancer, PC, Active Surveillance, Chemonaiive, OMN54, Aneustat (TM), PSA, BPH
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMN54Drug

    Also called Aneustat(TM)

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

Study groups in NCT03495479
Study groupRoleWhat they receive
OMN54 -TreatedSix-month, daily oral dosing in softgel capsules throughout the first 6 months of treat.
Receives: Drug: OMN54

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Prostate Specific Antigen

    Quarterly assessment of serum Prostate Specific Antigen (PSA)

    Measured: 12 months

  2. Changes in Tumor Size

    Changes in tumor size based on semi-annual MRI

    Measured: 12 months

  3. Changes in Urinary Flow

    Quartelry assessment of patient urinary flow based on patient IPSS Questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study startJan 2025 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495479
Sponsor's protocol ID
OMN54-PC-02
Acronym
CAMPAS
Status last verified
Oct 2021
First submitted
14 Jun 2016
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This is undecided and will be decided in consultation with the PI.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Omnitura Therapeutics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Prostate Specific Antigen (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

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