Clinical trial · Interventional
Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum
- 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, such as eflornithine, work in different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight prostate cancer by stopping the adrenal glands from producing androgens. Combining eflornithine with bicalutamide may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| eflornithine | Drug | — | UNRESOLVED |
| oral bicalutamide placebo | Drug | — | UNRESOLVED |
| oral eflornithine placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral eflornithine and oral bicalutamide once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.
- interventionNames
- Drug: bicalutamide
- Drug: eflornithine
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral eflornithine and oral bicalutamide placebo once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.
- interventionNames
- Drug: eflornithine
- Drug: oral bicalutamide placebo
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Localized disease * Paraffin blocks from diagnostic biopsies available * Planning to undergo brachytherapy or prostatectomy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 10.0 g/dL * WBC ≥ 3,500/mm\^3 * Platelet count ≥ 125,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL * SGOT and SGPT ≤ 2 times normal * No history of liver disease (e.g., hepatitis, cirrhosis, or jaundice) Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No symptomatic coronary artery disease * No uncontrolled hypertension * No acute myocardial infarction within the past year Other * Fertile patients must use effective contraception * No more than 10 decibels baseline hearing loss at any frequency by full bilateral audiometry within the past month * No hypersensitivity to eflornithine or bicalutamide * No other prior or active malignancy except nonmelanoma skin cancer or other cancer curatively treated at least 5 years ago with no evidence of recurrent or residual disease * No concurrent acute or chronic medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No other concurrent chemotherapy Endocrine therapy * More than 1 year since prior antiandrogen, luteinizing hormone-releasing hormone (LHRH) agonist, bicalutamide, finasteride, or diethylstilbestrol * No other concurrent antiandrogen, LHRH agonist, finasteride, or diethylstilbestrol Radiotherapy * See Disease Characteristics * No other concurrent radiotherapy Surgery * See Disease Characteristics
References
Publications (0)
Data not yet available