Clinical trial · Interventional
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
- 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 luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| estramustine phosphate sodium | Drug | Estramustine | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| ketoconazole | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| releasing hormone agonist therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Androgen blockade + immediate chemotherapy
- description
- Androgen blockade with immediate chemotherapy
- interventionNames
- Drug: bicalutamide
- Drug: docetaxel
- Drug: doxorubicin hydrochloride
- Drug: estramustine phosphate sodium
- Drug: flutamide
- Drug: ketoconazole
- Drug: paclitaxel
- Drug: releasing hormone agonist therapy
- Drug: vinblastine sulfate
- type
- EXPERIMENTAL
- label
- Androgen blockade + delayed chemotherapy
- description
- Androgen blockade with delayed chemotherapy
- interventionNames
- Drug: bicalutamide
- Drug: docetaxel
- Drug: doxorubicin hydrochloride
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the prostate * Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less * No clinical or radiographic evidence of disease * Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes * No metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 1.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL * Blood Urea Nitrogen (BUN) no greater than 1.2 times normal Cardiovascular: * No symptomatic heart disease * No history of myocardial infarction * No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism) Other: * No other major medical or psychiatric illness that would preclude study entry * No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer * No history of esophageal varices * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 weeks since prior vaccine therapy Chemotherapy: * At least 5 years since prior chemotherapy Endocrine therapy: * Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed * At least 1 year since prior androgen therapy Radiotherapy: * See Disease Characteristics * At least 5 years since prior radiotherapy to sites other than prostate Surgery: * See Disease Characteristics Other: * Concurrent warfarin allowed * Concurrent bisphosphonate therapy initiated prior to or after randomization allowed
References
Publications (1)
- BACKGROUNDSandler HM, Pienta KJ. Rationale for the Radiation Therapy Oncology Group Study RTOG P-0014. Rev Urol. 2003;5 Suppl 2(Suppl 2):S28-34. PMID 16986043