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A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer

M

Matrix Biomed

Status

Conditions

Prostate Cancer

Treatments

Drug: MBM-02 (Tempol)

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT04337099
MBI-11-01

Details and patient eligibility

About

A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg.

Full description

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Biochemical Recurrent Prostate Cancer

Exclusion criteria

Trial contacts and locations

1

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Central trial contact

Benji Crane

Data sourced from clinicaltrials.gov

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