Clinical trial · Interventional
Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
- 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)
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
Secondary outcomes (3)
- measure
- To compare changes in PSADT between the first and second six-month treatment periods for those in the placebo-treated group
- measure
- to correlate COX-2 expression in the patients' original prostate samples with biologic activity of celecoxib (when feasible)
- measure
- to correlate changes in plasma vascular endothelial growth factor (VEGF) levels in patients with biologic activity of celecoxib
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate cancer * Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart * PSA greater than or equal to 1.0 for men who had a prostatectomy * PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy) * PSA doubling time between 6 and 24 months * Participants must be either fully active and asymptomatic or symptomatic but fully ambulatory * Adequate bone marrow function, kidney function and liver function as evidenced by laboratory results Exclusion Criteria: * Evidence of metastatic disease * Prior hormonal therapy for recurrent prostate cancer * Prior chemotherapy for recurrent or metastatic prostate cancer * Radiation therapy within 6 months * Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs * Patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry * Patients taking selective COX-2 inhibitors or any NSAIDs other than aspirin within 8 weeks of study entry * Patients taking fluconazole, lithium or warfarin * History of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months * Any history of myocardial infarction in the past 12 months * Any uncontrolled, serious medical or psychiatric illness
References
Publications (0)
Data not yet available