Prostate CancerPhase 2NexrutineNCT01705652
Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients
A Phase 2 study testing Nexrutine 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
The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. 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?
- Nexrutine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 a histologic diagnosis of prostate cancer (in more than 1 core) with one of the following:
- Gleason > 6,
- Unilateral Gleason 6 in ≥ 3 cores,
- bilateral Gleason 6,
- PSA > 10.0 ng/ml.
- Age ≥18 years.
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- Has an ECOG Performance Status 0-2 or Karnofsky 60-100.
- Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥ 1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x institutional upper limit of normal (ULN)
- Signed informed consent
- No new, undiagnosed bone pain or has a negative bone scan. (within 2 months of consent) If there is no bone pain, then a bone scan is not required.
Who cannot join
- Has documented metastatic disease.
- Has received a prior chemotherapy or androgen ablation.
- Has received prior immunotherapy.
- Has been previously treated with Strontium, Samarium, other systemic radioisotopes or radiation therapy.
- Has diagnosis of congestive heart failure
- Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the counter aspirin and ibuprofen are allowed.
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- Is receiving any other investigational agents for cancer.
- Has a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of prostate cancer.
- Has a serious intercurrent illness with a life expectancy of less than 5 years.
- Has a concomitant medical, psychological, or social circumstance, which would interfere with compliance with the protocol treatment and follow-up.
- Use of any herbal or alternative regimens, which may have antineoplastic or hormonal activity (including but not limited to finasteride, dutasteride, Saw Palmetto, PC-SPES, shark cartilage, etc), is prohibited while receiving study treatment.
- Clinical stage T3 or T4 and PSA >10 ng/ml and Gleason > 8.
- Patient is to receive adjuvant androgen ablation with the radiation.
- EKG which shows a baseline QTc > 450 msec or ischemic changes. For ischemic changes, patient will be eligible if evaluated and cleared by internal medicine.
- Previous history of drug-induced QTc prolongation and/or concurrent treatment with medications that are known to produce or are suspected of QT prolongation.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio, study site: ALM VA Hospital
San Antonio, Texas, 78229
About this study
Official title: Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy
The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.
- Conditions
- Prostate Cancer
- Being tested
- Nexrutine
- Keywords
- nexrutine, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexrutineDrug
Also called bark extract of Phellodendron amurense
Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Nexrutine Surgery Group | Experimental | Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Receives: Drug: Nexrutine |
| Nexrutine Radiation Group | Experimental | Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Receives: Drug: Nexrutine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA (Prostate Specific Antigen)
PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery
Measured: 3 months post end of radiation treatment or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory P. Swanson, MD, The University of Texas Health Science Center at San Antonio
- Investigators
- Gregory P. Swanson, MD, Principal investigator, The University of Texas Health Science Center at San AntonioWilliam E. Jones, III, MD, Principal investigator, The University of Texas Health Science Center at San Antonio and ALM VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705652
- Sponsor's protocol ID
- HSC20100308H
- Acronym
- Nexrutine
- Status last verified
- May 2015
- First submitted
- 9 Oct 2012
- Last updated
- 11 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy
- ClinicalTrials.gov ID
- NCT01705652
- Acronym / sponsor ID
- Nexrutine / HSC20100308H
- Conditions
- Prostate Cancer
- Keywords
- nexrutine, prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: loss of funding
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Posted 11 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nexrutine Surgery Group | Experimental | Drug: NexrutineSurgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. |
| Nexrutine Radiation Group | Experimental | Drug: NexrutineRadiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the following:
- Age ≥18 years.
- Has an ECOG Performance Status 0-2 or Karnofsky 60-100.
- Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥ 1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x institutional upper limit of normal (ULN)
- Signed informed consent
Key exclusion criteria (15 listed)
- Has documented metastatic disease.
- Has received a prior chemotherapy or androgen ablation.
- Has received prior immunotherapy.
- Has been previously treated with Strontium, Samarium, other systemic radioisotopes or radiation therapy.
- Has diagnosis of congestive heart failure
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 |
|---|---|---|
| NexrutineAlso: bark extract of Phellodendron amurenseNexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment. | Drug | Nexrutine Radiation Group, Nexrutine Surgery Group |
Primary outcome
PSA (Prostate Specific Antigen)
Time frame: 3 months post end of radiation treatment or surgery
PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory P. Swanson, MD principal investigator
The University of Texas Health Science Center at San Antonio
William E. Jones, III, MD principal investigator
The University of Texas Health Science Center at San Antonio and ALM VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexrutine 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 11 Jun 2015. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PSA (Prostate Specific Antigen) (time frame: 3 months post end of radiation treatment or surgery). 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 11 Jun 2015.