A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for thetreatment of prostate cancer. The single patient will be exposed to orally administeredTEMPOL for up to 12 months at a maximum total daily dose of 800mg.
Localized therapy for prostate cancer is often curative; however, 20% to 30% of patients
experience a recurrence. Biochemical recurrence (BCR) occurs in an estimated 50,000
men/year in the U.S and is marked by a rising prostate specific antigen (PSA) after
definitive radical prostatectomy and/or radiation therapy for localized disease.
Continuous androgen deprivation therapy (ADT), in which serum testosterone is decreased
to a castrate level (less than 50 ng/dL) is a standard treatment in BCR. ADT is
associated with significant short term and long term toxicities, including declining
quality of life on treatment and increased risk of osteoporosis, diabetes, and
cardiovascular disease. MBM-02 is being tested as a novel non-hormonal agent with
improved biologic activity and better tolerability for use in biochemically recurrent
prostate cancer.
Drug: MBM-02 (Tempol)
Study drug will be administered orally using the capsule formulation (200 mg). The study
drug will be administered 7 days a week for the entire treatment period.
Other Name: Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Inclusion Criteria:
- Biochemical Recurrent Prostate Cancer
Exclusion Criteria:
-
Prostate Oncology Specialists
Marina Del Rey, California, United States
Investigator: Krista Yasuda
Investigator: Mark Scholz, MD
Benji Crane
16264376506
bjcrane@matrixbiomed.com