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

• ClinicalTrials.gov Identifier: NCT01705652
• Recruitment Status: Terminated
• First Posted: October 12, 2012
• Results First Posted: June 11, 2015
• Last Update Posted: June 11, 2015
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): Gregory P. Swanson, MD, The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Nexrutine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: July 2011
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nexrutine Surgery Group; Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.	Drug: Nexrutine; Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.; Other Name: bark extract of Phellodendron amurense
Experimental: Nexrutine Radiation Group; 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 Name: bark extract of Phellodendron amurense

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Gregory P. Swanson, MD, Clinical Professor, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT01705652
• Other Study ID Numbers: HSC20100308H
• First Posted: October 12, 2012
• Results First Posted: June 11, 2015
• Last Update Posted: June 11, 2015
• Last Verified: May 2015

Keywords provided by Gregory P. Swanson, MD, The University of Texas Health Science Center at San Antonio:

nexrutine; prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases