Prostate CancerEarly Phase 1NCT04403568
Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
A Early Phase 1 study testing Ursolic Acid and Curcumin in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ursolic Acid and Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Dec 2023
- Phase
- Early Phase 1
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy
- Be able to give informed consent
- Be age 18 or older
- Able to stop supplements
Who cannot join
- Unable to give informed consent
- Age < 18
- High-risk prostate cancer or suspected metastasis
- Unable to swallow pills
- Unable to stop supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect
Read the detailed description
Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:
Cohort 1:
- Ursolic Acid (150 mg) BID (twice a day)
Cohort 2:
- Curcumin (600 mg) BID
Cohort 3:
- Ursolic Acid (150 mg) and Curcumin (600 mg) BID
The study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3.
- Conditions
- Prostate Cancer
- Being tested
- Ursolic Acid, Curcumin
- Keywords
- Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursolic AcidDrug
Ursolic Acid 150mg
CurcuminDrug
Curcumin 600mg
| Study group | Role | What they receive |
|---|---|---|
| Ursolic Acid | Experimental | Administration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy Receives: Drug: Ursolic Acid |
| Curcumin | Experimental | Administration of Curcumin to subjects who are scheduled to undergo radical prostatectomy Receives: Drug: Curcumin |
| Ursolic Acid and Curcumin | Experimental | Administration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy Receives: Drug: Ursolic Acid; Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, frequency, duration, and relation of toxicity events
Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC/UA combination, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.
Measured: Baseline to 8 weeks
Peak serum concentration
Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.
Measured: Baseline to 8 weeks
Time to reach peak serum concentration
The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.
Measured: Baseline to 8 weeks
Half-life
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Levels of UA, CURC, and metabolites in prostate tissue
Identify the presence and levels of UA, CURC and their metabolites in prostate tissue using HPLC.
Measured: Baseline to 8 weeks
Immunohistochemistry measurement
Immunohistochemistry of proportion of nuclear p65 NFkB staining before and after prostatectomy on FFPE samples will be completed.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study startOct 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: No subjects were enrolled in this study, the PI will seek funding and revise the protocol for resubmisson at a later date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Liss, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403568
- Sponsor's protocol ID
- HSC20190735H
- Status last verified
- Sep 2021
- First submitted
- 21 May 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial Testing the Synergism of Phytonutrients, Curcumin and Ursolic Acid, to Target Molecular Pathways in the Prostate
- ClinicalTrials.gov ID
- NCT04403568
- Acronym / sponsor ID
- HSC20190735H
- Conditions
- Prostate Cancer
- Keywords
- Radical Prostatectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled in this study, the PI will seek funding and revise the protocol for resubmisson at a later date
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A proof of concept clinical trial to assess the synergism of curcumin (CURC) and ursolic acid (UA). Before further testing within formal cancer clinical trials, we must (1) evaluate the bioavailability and safety, (2) confirm the presence of metabolites in the target organ, and (3) validate the appropriate mechanism of effect
Detailed description
Once a subject is identified that may meet eligibility criteria, the physician and/or study investigators will be alerted to the potential candidate and will introduce the study to the patient at their standard of care (SOC) appointment or via telephone. Patients will be given the option for enrollment and if they agree, informed consent will be discussed and obtained provided they meet all inclusion/exclusion criteria. Following informed consent, subjects will be assigned to one of the following cohorts:
Cohort 1:
- Ursolic Acid (150 mg) BID (twice a day)
Cohort 2:
- Curcumin (600 mg) BID
Cohort 3:
- Ursolic Acid (150 mg) and Curcumin (600 mg) BID
The study team aim to enroll 10 subjects who will complete the study into each cohort for a total of 30 completers. Subjects will be enrolled on a rolling basis with the first ten subjects assigned to Cohort 1, the next ten subjects assigned to Cohort 2, and the last 10 subjects assigned to Cohort 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be assigned to one of 3 cohorts, starting with cohort 1 and progressing to cohort 3
| Arm | Type | Receives |
|---|---|---|
| Ursolic Acid | Experimental | Drug: Ursolic AcidAdministration of Ursolic Acid to subjects who are scheduled to undergo radical prostatectomy |
| Curcumin | Experimental | Drug: CurcuminAdministration of Curcumin to subjects who are scheduled to undergo radical prostatectomy |
| Ursolic Acid and Curcumin | Experimental | Drug: Ursolic Acid, Drug: CurcuminAdministration of Ursolic Acid and Curcumin to subjects who are scheduled to undergo radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have proven diagnosis of prostate cancer with Gleason Group 3 or lower and planning to undergo radical prostatectomy
- Be able to give informed consent
- Be age 18 or older
- Able to stop supplements
Key exclusion criteria (5 listed)
- Unable to give informed consent
- Age < 18
- High-risk prostate cancer or suspected metastasis
- Unable to swallow pills
- Unable to stop supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursolic AcidUrsolic Acid 150mg | Drug | Ursolic Acid, Ursolic Acid and Curcumin |
| CurcuminCurcumin 600mg | Drug | Curcumin, Ursolic Acid and Curcumin |
Primary outcome
Number, frequency, duration, and relation of toxicity events
Time frame: Baseline to 8 weeks
Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC/UA combination, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.
Peak serum concentration
Time frame: Baseline to 8 weeks
Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.
Time to reach peak serum concentration
Time frame: Baseline to 8 weeks
The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.
Half-life
Time frame: Baseline to 8 weeks
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
2 secondary outcomes
Levels of UA, CURC, and metabolites in prostate tissue
Time frame: Baseline to 8 weeks
Immunohistochemistry measurement
Time frame: Baseline to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Liss, MD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ursolic Acid and Curcumin in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 4 inclusion and 5 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number, frequency, duration, and relation of toxicity events (time frame: Baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021.