Clinical trial · Interventional
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
NCT00002855CI-TRIAL-00035534completedPhase 3ClinicalTrials.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 hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Estramustine Phosphate Sodium | Drug | Estramustine | ALIAS |
| Flutamide | Drug | Flutamide | ALIAS |
| Ketoconazole | Drug | — | UNRESOLVED |
| Nilutamide | Drug | Nilutamide | ALIAS |
| Therapeutic Hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
- interventionNames
- Drug: Bicalutamide
- Drug: Flutamide
- Drug: Nilutamide
- Procedure: Conventional Surgery
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks rest. Maintained on hydrocortisone both during treatment and during rest.
- interventionNames
- Drug: Doxorubicin hydrochloride
- Drug: Estramustine Phosphate Sodium
- Drug: Ketoconazole
- Drug: Therapeutic Hydrocortisone
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven acinar adenocarcinoma of the prostate * Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous "definitive" local therapy * No CNS metastases * No histologic subtypes, such as pure ductal or any component of small cell carcinoma * Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 3 years Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL * Transaminase no greater than 4 times upper limit of normal Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * No evidence of bifascicular block on EKG * No evidence of active ischemia on EKG * No prior history of transient ischemic attack * No evidence of congestive heart failure Other: * No active peptic ulcer disease * No regular use of antacid or H2 blockers * No known or predicted achlorhydria * No concurrent use of terfenadine, astemizole, omeprazole, or cisapride * No second malignancy unless curatively treated * No history of deep venous thrombosis * No history of pulmonary embolism * No serious co-morbidity * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic systemic therapy Endocrine therapy: * Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary * No androgen deprivation therapy within 1 year prior to study Radiotherapy: * No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation) * Prior definitive radiotherapy to the prostate and/or one metastatic site allowed * At least 8 weeks since radiotherapy to the pelvis * At least 3 weeks since radiotherapy to a single metastatic site Surgery: * Prior prostatectomy allowed Other: * No concurrent anti-anginal therapy or aggressive anticoagulants
References
Publications (1)
- RESULTMillikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. doi: 10.1200/JCO.2007.15.9830. Epub 2008 Nov 24. PMID 19029421