Prostate Cancer
Conditions
Keywords
nexrutine, prostate cancer
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.
Interventions
DRUGNexrutine
Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA (Prostate Specific Antigen) | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 7/20/2011 to 4/16/2013 from the ALM VA South Texas urology clinic.
Pre-assignment details
Subjects were required to have a diagnosis of prostate cancer and treatment planned by surgery or radiation therapy.. Subjects were excluded if they were currently taking anticoagulation medications, or medications that are known to produce or are suspected of QT prolongation.
Participants by arm
| Arm | Count |
|---|---|
| Nexrutine Surgery Group Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery. | 9 |
| Nexrutine Radiation Group Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation. | 12 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | non-compliance | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Nexrutine Surgery Group | Nexrutine Radiation Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 15 Participants |
| Region of Enrollment United States | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 12 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
PSA (Prostate Specific Antigen)
PSA decline to \< 1.0 ng/ml at 3 months post end of radiation or surgery
Time frame: 3 months post end of radiation treatment or surgery
Population: Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation Group | PSA (Prostate Specific Antigen) | 2 participants |
| Surgery Group | PSA (Prostate Specific Antigen) | 6 participants |