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

NCT01705652 | Terminated Phase 2 Results DMC

• 1 other identifier: HSC20100308H
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

nexrutine; prostate cancer

Outcome Measures

Primary Outcomes (1)

• PSA (Prostate Specific Antigen)

  PSA decline to \< 1.0 ng/ml at 3 months post end of radiation or surgery

  3 months post end of radiation treatment or surgery

Study Arms (2)

Nexrutine Surgery Group

EXPERIMENTAL

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

Drug: Nexrutine

Nexrutine Radiation Group

EXPERIMENTAL

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

Drug: Nexrutine

Interventions

Nexrutine DRUG

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

Also known as: bark extract of Phellodendron amurense

Nexrutine Radiation Group; Nexrutine Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nexrutine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gregory P. Swanson, MD
• Organization: The University of Texas Health Science Center at San Antonio Department of Radiation Oncology

swansong@uthscsa.edu

210-450-1109

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 11, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-05

Locations

US (1)