At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓High-risk disease defined by Stage T2b or surgically resectable T3, OR PSA ≥15 ng/mL, OR Gleason >4+3
- ✓At least 50% chance of prostate cancer recurrence within 5 years
- ✓Planned prostatectomy as primary therapy
- ✕No evidence of bone metastases required
- ✕Lymph nodes must be ≤2 cm on pelvic CT scan (if PSA >40 ng/mL)
- ✕No other malignancy within past 5 years except nonmelanoma skin cancer
- ✕No peripheral neuropathy grade 2 or greater
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating docetaxel, mitoxantrone hydrochloride, and 1 other intervention for Prostate Cancer. Completed, enrolled 57 participants across 2 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer.
Study Details
Timeline
Interventions
35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.
Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.
Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.