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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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
Miriam Hospital
Providence, Rhode Island, United States
Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation
The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2
Time frame: 2 mos
Number of Participants Experiencing a Toxicity Associated With Cabazitaxel and Adjuvant Radiation Following Prostatectomy for Patients With Stage 3 Prostate Cancer and for Patients With a PSA Elevation Post-Prostatectomy.
Assess toxicity using CTCAE version 4.0. Number of patients who experienced a toxicity on the study. Not all toxicities are related to study treatment. Of note, there were no serious adverse events on this trial.
Time frame: During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.
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