Clinical trial · Interventional
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
NCT00587431CI-TRIAL-00071133completedPhase 2Results postedClinicalTrials.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)
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| GnRh (Leuprolide) | Drug | — | UNRESOLVED |
| Testosterone Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: GnRh (Leuprolide)
- Drug: Testosterone Gel
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: GnRh (Leuprolide)
- Drug: Testosterone Gel
Primary outcomes (1)
- measure
- PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
- timeFrame
- Conclusion of the study (at 6 months then at 18 months post-treatment)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC. * Patient must have a serum testosterone \> 180 ng/dl. * Karnofsky performance status (KPS)\>\_70%. * Patients must have adequate organ function as defined by the following * laboratory criteria: * WBC \>\_ 3500/mm3 * ANC \>\_1500/mm3 * Platelet count \>100,000/mm3 * Hemoglobin \>8.0g/dL * Creatinine \<1.6mg/dl * Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL) * SGOT and SGPT If alkaline phosphatase is \_\< 2.5 x ULN, any elevations in * AST/ALT; OR if AST/ALT is \_\<1.5 x ULN, any elevation in alkaline phos * Prior hormonal therapy is allowed as: 1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy). 2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy). * Patients must be at least 18 years of age. * Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment Exclusion Criteria: * Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease. * Uncontrolled serious active infection. * Anticipated survival of less than 3 months. * Active CNS or epiduraltumor * Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests * Peripheral neuropathy \>\_ grade 3. * Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80. * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment. * Prior chemotherapy * Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
References
Publications (0)
Data not yet available
No reference posted for this study.