Clinical trial NCT01705652: Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients
Official title: Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: nexrutine
prostate cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: PSA (Prostate Specific Antigen)
timeFrame: 3 months post end of radiation treatment or surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio, study site: ALM VA Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Gregory P. Swanson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio and ALM VA Hospital
name: William E. Jones, III, MD
role: PRINCIPAL_INVESTIGATOR
References: