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Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gregory P. Swanson, MD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01705652
First received: October 9, 2012
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Nexrutine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • PSA (Prostate Specific Antigen) [ Time Frame: 3 months post surgery or end of radiation treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexrutine

Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.

Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.

Drug: Nexrutine
Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.
Other Names:
  • Nexrutine
  • bark extract of Phellodendron amurense

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age ≥18 years.
  3. Has an ECOG Performance Status 0-2 or Karnofsky 60-100.
  4. 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)
  5. Signed informed consent
  6. 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.

Exclusion Criteria:

  1. Has documented metastatic disease.
  2. Has received a prior chemotherapy or androgen ablation.
  3. Has received prior immunotherapy.
  4. Has been previously treated with Strontium, Samarium, other systemic radioisotopes or radiation therapy.
  5. Has diagnosis of congestive heart failure
  6. Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the counter aspirin and ibuprofen are allowed.
  7. Is receiving any other investigational agents for cancer.
  8. Has a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of prostate cancer.
  9. Has a serious intercurrent illness with a life expectancy of less than 5 years.
  10. Has a concomitant medical, psychological, or social circumstance, which would interfere with compliance with the protocol treatment and follow-up.
  11. 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.
  12. Clinical stage T3 or T4 and PSA >10 ng/ml and Gleason > 8.
  13. Patient is to receive adjuvant androgen ablation with the radiation.
  14. 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.
  15. Previous history of drug-induced QTc prolongation and/or concurrent treatment with medications that are known to produce or are suspected of QT prolongation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705652

Locations
United States, Texas
The University of Texas Health Science Center at San Antonio, study site: ALM VA Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Gregory P. Swanson, MD The University of Texas Health Science Center at San Antonio
Principal Investigator: William E. Jones, III, MD The University of Texas Health Science Center at San Antonio and ALM VA Hospital
  More Information

No publications provided

Responsible Party: Gregory P. Swanson, MD, Clinical Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01705652     History of Changes
Other Study ID Numbers: HSC20100308H
Study First Received: October 9, 2012
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
nexrutine
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014