MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer

Inclusion Criteria

• •1. Male 18 years or older;
• •2. Histologically or cytologically confirmed diagnosis of prostate cancer;
• •3. Patient must have had previous treatment with definitive surgery or radiation therapy, cryoablation, or brachytherapy;
• •4. Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure. Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
• •5. Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy:
• •1. For radical prostatectomy the threshold for this study is PSA ≥ 0.8ng/mL
• •2. For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition).
• •6. PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached;
• •7. PSA doubling time ≤ 12 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab.
• •8. ECOG performance status less than or equal to 2;
• •9. Ability to swallow the study drugs;
• •10. If a male with a female partner of child bearing potential, adequate methods of contraception must be employed;
• •11. If male, no sperm donation for 90 days until after the conclusion of the study;
• •12. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• •13. Be able to participate for the full term of the clinical investigation;
• •14. Have a Karnofsky performance status of \>70;
• •15. Have a life expectancy ≥ 6 months; and
• •16. Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
• •Hematology:
• •Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood
• •Hepatic:
• •Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5 x ULN
• •Renal:
• •creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CrCl female = 0.85 x (CrCl male)