Clinical trial · Interventional
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
- 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)
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Casodex | Drug | Bicalutamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Estramustine | Drug | Estramustine | ALIAS |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
| Zoladex | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel Followed by Radical Prostatectomy
- description
- Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy
- interventionNames
- Drug: Docetaxel
- Drug: Dexamethasone
- Drug: Estramustine
- Drug: Zoladex
- Drug: Casodex
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists
- timeFrame
- status post prostectomy
- description
- One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Potential candidate for radical prostatectomy * Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive * ECOG Performance Status 0-1 * WBC \> 3,000 ul * HCT \> 30% * PLT \> 100,000/ul * LFTS within normal limits Exclusion Criteria: * Prior hormones, radiation or chemotherapy for prostate cancer * Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year * Evidence of active infection * Significant peripheral neuropathy
References
Publications (0)
Data not yet available