Clinical trial · Interventional
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
NCT00165399CI-TRIAL-00033396completedPhase 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)
The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer. This study will attempt to: * stop or slow the growth of disease * gain information about prostate cancer * evaluate the effectiveness and side effects of the study drug
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Casodex | Drug | Bicalutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Estramustine | Drug | Estramustine | ALIAS |
| Zoladex | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To determine the PSA response rate and duration of response
- measure
- to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate * Previous treatment with either radical prostatectomy or radiation therapy * Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart * Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value * ECOG performance status 0-1 * ANC \> 1,500/mm3 * Platelet counts \> 100,000/mm3 * SGOT and/or SGPT may be up to 2.5 x ULN Exclusion Criteria: * Documented local recurrence of prostate cancer or documented metastatic disease * History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin * Medical condition requiring the use of concommitant corticosteroids * Active infection * Significant cardiac disease, angina pectoris or myocardial infarction within six months * Prior chemotherapy including estramustine, suramin * Active thrombophlebitis or history of thromboembolic events in the six months preceding study treatment * Clinically significant neuropathy * Elevated bilirubin above ULN
References
Publications (0)
Data not yet available
No reference posted for this study.