Clinical trial · Interventional
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Phase I/II Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
NCT00017563CI-TRIAL-00027262completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel, Mitoxantrone, Conventional Surgery
- description
- Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy
- interventionNames
- Drug: docetaxel
- Drug: mitoxantrone hydrochloride
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.
- timeFrame
- Every 3 months after surgery for up to 5 years.
- description
- Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA \> 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* High-risk, as defined by 1 of the following:
* Stage T2b (palpable bilateral involvement) or surgically resectable T3
* PSA 15 ng/mL or greater
* Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4)
* At least a 50% chance of prostate cancer recurrence within 5 years
* Planned prostatectomy as primary therapy
* No evidence of bone metastases by bone scan
* No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan (scan required only if PSA greater than 40 ng/mL)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Eastern Cooperative Oncology Group(ECOG) 0-2
Life expectancy:
* At least 10 years
Hematopoietic:
* White Blood Cell(WBC) at least 3,000/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Conjugated bilirubin no greater than upper limit of normal (ULN)
* Alkaline phosphatase no greater than 4 times ULN
* Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
Renal:
* Not specified
Cardiovascular:
* Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan
Other:
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No significant active medical illness that would preclude study therapy
* No peripheral neuropathy grade 2 or greater
* No hypersensitivity to drugs formulated with polysorbate-80
* No significant contraindications to corticosteroids
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior cytotoxic chemotherapy
* No other concurrent cytotoxic chemotherapy
Endocrine therapy:
* No prior or concurrent conventional hormonal therapy
Radiotherapy:
* No prior or concurrent radiotherapy (external beam or brachytherapy)
Surgery:
* See Disease Characteristics
Other:
* No prior or concurrent cryotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.