A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer

Study Status

Open to Enrollment

Study Description

This clinical trial is studying docetaxel and leuprolide or gosserlin to see how they work when given before surgery, compared with surgery alone in treating patients with high-risk localized prostate cancer.

Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.

There are 2 arms in this study:

  • Arm 1: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly once every 4 or 12 weeks for 18-24 weeks. They also receive docetaxel IV over 1 hour on day 1 (study entry). Treatment with docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.
  • Arm 2: Within 60 days after randomization, patients undergo radical prostatectomy with staging pelvic lymphadenectomy.

Disease Status and/or Stage

High Risk, Clinically Localized Prostate Cancer

Sponsor

Cancer and Leukemia Group B, National Cancer Institute

Key Eligibility

  • Men age 18 and older
  • Confirmed prostate cancer
  • Clinically localized, stage T1-3a disease
  • Deemed an appropriate candidate for radical prostatectomy
  • Additional eligibility criteria discussed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

Protocol ID

CALGB 90203

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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