At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate with high-risk features: T3/T4, or T1-2 with Gleason 8-10, or T1-2 with Gleason 7 and PSA >10 ng/mL, or T1-2 with any Gleason and PSA >20 ng/mL
- ✓No evidence of metastatic disease on staging imaging (chest x-ray, bone scan, CT abdomen/pelvis)
- ✓Age >18 years
- ✓ECOG Performance Status 0-1
- ✕Documented metastatic disease
- ✕Life expectancy <10 years due to comorbid illness
- ✕Myocardial infarction, significant change in anginal pattern within 1 year, or current congestive heart failure (NYHA Class 2 or higher)
- ✕Severe hypersensitivity reaction to docetaxel or polysorbate 80
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere®), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate
In Brief
A Phase 2 clinical trial evaluating docetaxel, leuprolide acetate, and 1 other intervention for Prostate Cancer. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
RATIONALE: 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 leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer.
Study Details
Timeline
Interventions
Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.
Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.
The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.