Clinical trial · Interventional
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation
- 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: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
- interventionNames
- Drug: celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Placebo-control
- description
- Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
- interventionNames
- Drug: Placebos
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed localized adenocarcinoma of the prostate with one or more of the following: * Gleason sum at least 7 * Prostate-specific antigen (PSA) at least 15 ng/mL * Clinical stage T2b or T2c (stage II) * Any combination of PSA, clinical stage, or Gleason sum with an estimated risk of capsular penetration greater than 45% * At least 3 positive core biopsies * Planned radical prostatectomy * No metastatic disease secondary to prostate cancer PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL * No history of bleeding disorders Hepatic: * Bilirubin less than 1.5 mg/dL * AST/ALT less than 1.5 times upper limit of normal * No viral hepatitis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * No history of hypersensitivity and/or adverse reactions to salicylates * No allergy to sulfa-containing medications * No other active malignancy within the past 5 years except superficial bladder cancer or nonmelanoma skin cancer * No medical or psychiatric problem that would preclude study participation * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunologic therapy for prostate cancer Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * No prior androgen ablation for prostate cancer * At least 4 weeks since prior hormonal therapy and recovered * At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of glucocorticoids * No concurrent glucocorticoids Radiotherapy: * At least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and recovered Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery and recovered Other: * No prior investigational therapy for prostate cancer * No prior or concurrent chronic anticoagulants * No prior cyclo-oxygenase-2 inhibitor therapy (e.g., rofecoxib or celecoxib) * At least 4 weeks since prior initiation of vitamins (except multivitamin) or herbs with known effects on prostate function (PSA) * At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of aspirin (greater than 100 mg/day) or non-steroidal anti-inflammatory drugs (NSAIDs) * At least 24 hours since prior use and no concurrent use of any of the following: * Over-the-counter (OTC) or prescription products containing aspirin or NSAIDs; OTC products containing bismuth subsalicylate, sodium salicylate, and/or magnesium salicylate; choline salicylate; ranitidine; cimetidine; famotidine; or lansoprazole * No aspirin (100 mg/day) within 1 week prior to surgery * No concurrent addition of vitamins or herbal supplements
References
Publications (1)
- RESULTAntonarakis ES, Heath EI, Walczak JR, Nelson WG, Fedor H, De Marzo AM, Zahurak ML, Piantadosi S, Dannenberg AJ, Gurganus RT, Baker SD, Parnes HL, DeWeese TL, Partin AW, Carducci MA. Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers. J Clin Oncol. 2009 Oct 20;27(30):4986-93. doi: 10.1200/JCO.2009.21.9410. Epub 2009 Aug 31. PMID 19720908