Clinical trial · Interventional
Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for 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)
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| estramustine phosphate sodium | Drug | Estramustine | ALIAS |
| ketoconazole | Drug | — | UNRESOLVED |
| therapeutic hydrocortisone | Drug | — | UNRESOLVED |
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 that was continuously treated with androgen suppression
* Rising prostate-specific antigen (PSA), defined as PSA \> 5 ng/mL, rising on 2 consecutive measurements at least 4 weeks apart
* Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis
* Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:
* Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)
* At least 4 weeks continued rise in PSA after flutamide or nilutamide (6 weeks for bicalutamide)
* Testosterone less than 50 ng/dL
* Patients who have not undergone surgical castration must continue primary androgen suppression to maintain castrate levels of testosterone
* No progressive or measurable local or metastatic disease (including bone metastases)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* SGOT no greater than 2 times upper limit of normal
* Bilirubin no greater than 1.5 mg/dL
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* No American Heart Association class III or IV heart disease
* No uncontrolled congestive heart failure
* No life-threatening cardiac arrhythmias
Other:
* Fertile patients must use effective contraception
* No other prior malignancy unless curatively treated and disease-free for appropriate time period for specific cancer
* No preexisting peripheral neuropathy greater than grade 1
* No known hypersensitivity to polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 5 years since prior systemic chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior hydrocortisone
* No prior ketoconazole
Radiotherapy:
* At least 28 days since prior radiotherapy to primary site
* No prior palliative radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* Recovered form prior therapy
* At least 7 days since prior parenteral antibiotics for active infection
* No concurrent digitalis
* No concurrent H\_2 blockers or proton pump inhibitors (arm I only)
* Concurrent bisphosphonates allowed provided they were initiated prior to study therapyReferences
Publications (1)
- RESULTWalczak JR, Carducci MA; Eastern Cooperative Oncology Group E1899. Phase 3 randomized trial evaluating second-line hormonal therapy versus docetaxel-estramustine combination chemotherapy on progression-free survival in asymptomatic patients with a rising prostate-specific antigen level after hormonal therapy for prostate cancer: an Eastern Cooperative Oncology Group (E1899), Intergroup/Clinical Trials Support Unit study. Urology. 2003 Dec 29;62 Suppl 1:141-6. doi: 10.1016/j.urology.2003.09.006. PMID 14747052