NCT00669162

Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer

A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO (Tumor-3, Node-0) Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).

Detailed description

After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed. Participants will then be started on the protocol specific hormonal therapy for a total of 6 months. After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments. The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx) once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated radiation therapy (IMRT). Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the radiotherapy treatments.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	20mg/m2 IV weekly for 7 weeks
RADIATION	Radiation Therapy	66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx
DRUG	Casodex and Zoladex (or Lupron)	Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-08-01
• Completion: 2017-04-01
• First posted: 2008-04-29
• Last updated: 2019-07-24
• Results posted: 2019-07-24

Locations

1 site across 1 country: United States