Analyzing data in the Cancer Research Institute

Protox Phase IIa Clinical Trial

The purpose of this study is to determine the safety and tolerance of different injection schemes of PRX302, given by local injection (shot) into the prostate in men with localized recurrence of prostate cancer.

Are you a candidate?

Inclusion Criteria

Exclusion Criteria

Prescription for Health, Experimental Prostate Cancer Treatment

Contact Us

protoxstudy@swmail.sw.org

Nancy Bowman, R.N., C.R.C.

2401 S. 31st St.

Temple, Texas 76508

254-724-6294

Richard Castillo, C.R.C.

2401 S. 31st St.

Temple, Texas 76508

254-724-9981

Phase I History

Protox Successfully Doses First Patient in Prostate Cancer Trial Using PRX302

About the Protox trial

Protox Therapeutics, Inc., has launched a Phase IIa research study of an investigational drug, PRX302, with participating subjects that have recurrent prostate cancer after radiation therapy or brachytherapy.

An investigational drug is one that is under study but does not have permission from the U.S. Food and Drug Administration (FDA) or any regulatory authority to be legally marketed and sold.

The investigational drug, PRX302, is a pro-toxin, which can kill cells by a mechanism that does not require cells to be growing or dividing. PRX302 is being developed for treatment of prostate cancer.

To date, 24 subjects with recurrent prostate cancer have been treated with PRX302 and majority of the subjects did not show serious side effects related to the drug.

Purpose of Study

The purpose of this study is to determine the safety and tolerance of different injection schemes of PRX302, given by local injection (shot) into the prostate in men with localized recurrence of prostate cancer.

Because this is a research study, PRX302 will be given to subjects only during this study and not after the study is over.

A total of approximately 30 subjects at up to six institutions will take part in this study. Approximately 15 subjects from Scott & White are expected to participate.

Duration

Patient participation is anticipated to take 13 months to complete, which will include:

• Screening
  • Labs, physical examination, vital sign, urine sample, EKG
  • Radiographic images and biopsy, if not previously done
• Day of procedure
• Up to nine follow-up visits