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

NCT ID: NCT01705652

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-03-31

Brief 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. 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nexrutine Surgery Group

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

Group Type: EXPERIMENTAL

Nexrutine

Intervention Type: DRUG

Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.

Nexrutine Radiation Group

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

Group Type: EXPERIMENTAL

Nexrutine

Intervention Type: DRUG

Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.

Interventions

Nexrutine

Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.

Intervention Type: DRUG

Other Intervention Names

bark extract of Phellodendron amurense

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Gregory P. Swanson, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory P. Swanson, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

William E. Jones, III, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio and ALM VA Hospital

Locations

The University of Texas Health Science Center at San Antonio, study site: ALM VA Hospital

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20100308H

Identifier Type: -

Identifier Source: org_study_id