NCT01650285

Cabazitaxel and Radiation For Patients With Prostate Cancer

Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL) Following Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is a high relapse rate for patients who have undergone prostatectomy and have pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle involvement (pathologic stage 3 disease). While adjuvant radiation improves progression-free and overall survival, approximately half of these patients will develop recurrence. Similarly, radiation therapy has become the standard salvage therapy for patients with rising PSA \>0.1 - \< 2.0 ng/mL. In common solid tumors such as NSCLC, head and neck cancer and upper gastrointestinal cancers, the addition of chemotherapy to radiation improves survival. It is hypothesized that the addition of radiosensitizing chemotherapy to standard adjuvant radiation will improve survival in patients with stage 3 prostate cancer after prostatectomy and patients with rising PSA \< 2.0 ng.mL without detectable disease. Taxanes are powerful radiation enhancers since they synchronize tumor cells in G2/M the most radiosensitive phase of the cell cycle.17,18 Cabazitaxel is the most active taxane in the treatment of prostate cancer. Therefore, we propose a phase I study establishing the optimal dose of cabazitaxel with adjuvant radiation for stage 3 prostate cancer after prostatectomy (PSA undetectable - \< 2.0 ng/mL). and for patients with persistent or rising PSA post prostatectomy (PSA \>0.1 - \< 2.0 ng/mL).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Dose Level Day 1, 22, 43 1. 5.0 mg/m2 2. 10.0 mg/m2 3. 15.0 mg/m2 4. 20.0 mg/m2

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-07-26
• Last updated: 2022-03-04
• Results posted: 2015-06-29

Locations

1 site across 1 country: United States