Clinical trial · Interventional
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
NCT00005096CI-TRIAL-00028629completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel
- description
- Docetaxel given via iv at determined dose once a week for 4 weeks
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- 2 Months, 6 Months
- description
- Wilcoxon Signed Rank Test
Secondary outcomes (1)
- measure
- Percentage of Participants with mild to moderate toxicity
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Potential candidate for radical prostatectomy
* Any of the following:
* Clinical stage T3 patients
* Serum PSA at least 20 ng/mL
* Gleason score 8-10
* Clinical T2 disease and either of the following:
* MRI evidence of seminal vesicle involvement
* Gleason 4+3 cancer with either 5 or 6 biopsies positive
* CALGB 0-1
* WBC greater than 3,000/mm3
* Hematocrit greater than 30%
* Platelet count greater than 100,000/mm3
* SGOT, total bilirubin within normal limits
* Signed Informed consent
Exclusion Criteria:
* No prior hormones, radiation or chemotherapy for prostate cancer
* Evidence of serious active infectionReferences
Publications (0)
Data not yet available
No reference posted for this study.