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

Study Overview
=================
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.

Official Title
-----------------
Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Nexrutine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexrutine Surgery Group<br>Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. | Drug: Nexrutine<br>* Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.<br>* Other names: bark extract of Phellodendron amurense;|
| Experimental: Nexrutine Radiation Group<br>Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. | Drug: Nexrutine<br>* Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.<br>* Other names: bark extract of Phellodendron amurense;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nexrutine, prostate cancer