Clinical trial · Interventional
R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy, Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease
NCT00045123CI-TRIAL-00013059unknownPhase 2ClinicalTrials.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. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.
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 |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| tarenflurbil | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed localized adenocarcinoma of the prostate (from a pre-operative core biopsy, surgical specimen, or post-therapy core biopsy)
* Gleason score 5-10 at diagnosis (the highest score is used if multiple scores are available)
* Must have undergone 1 of the following curative treatment strategies:
* Radical prostatectomy
* Not a candidate for radiotherapy
* Radical prostatectomy followed by radiotherapy at the time of surgery or any time thereafter
* Radiotherapy of the prostate and/or surrounding structures by external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of EBRT and BT
* Must have 3 consecutive rising prostate-specific antigen (PSA) measurements OR meets slope criteria
* Biochemical failure, meeting 1 of the following criteria:
* PSA at least 0.2 ng/mL post radical prostatectomy
* PSA greater than 1.5 ng/mL after radiotherapy or appropriate calculated slope
* Testosterone at least 100 ng/mL
* No rise in PSA with concurrent clinically active prostatitis
* No metastatic prostate cancer
* PSA no greater than 20.0 ng/mL
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 2,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST or ALT no greater than 2 times upper limit of normal
Renal
* Creatinine no greater than 2.0 mg/dL
Cardiovascular
* No uncontrolled cardiac conditions
* No New York Heart Association class III or IV heart disease
Gastrointestinal
* No active ulcer disease diagnosed within the past 3 months
* No upper gastrointestinal bleed requiring a transfusion within the past 3 years
* No non-steroidal anti-inflammatory drug (NSAID)-associated ulcers within the past 5 years
Other
* No known hypersensitivity to NSAIDs, including COX-2-specific inhibitors (e.g., celecoxib or rofecoxib)
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
* No active systemic infections
* No other serious uncontrolled medical condition
* No dementia or altered mental status
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
Chemotherapy
* More than 5 years since prior cytotoxic chemotherapy for other malignant disease
* No prior cytotoxic chemotherapy for prostate cancer
* No concurrent chemotherapy
Endocrine therapy
* More than 9 months since prior androgen-deprivation therapy other than as cytoreductive therapy (neoadjuvantly or adjuvantly for less than 9 months) with the intent to cure
* More than 3 months since prior cyproterone, finasteride, diethylstilbestrol, megestrol, or other hormonally active (antiandrogen or antiprostate) therapies
Radiotherapy
* See Disease Characteristics
* No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other radioisotope materials for palliative intent or metastasis intervention
* Concurrent iodine I 125 or palladium Pd 103 for primary brachytherapy with curative intent allowed
Surgery
* See Disease Characteristics
* More than 8 weeks since prior major surgery and recovered
* No prior orchiectomy
Other
* More than 1 month since prior PC-SPES
* More than 1 month since prior investigational agents or devices (6 months for other investigational therapy for prostate cancer)
* No prior bisphosphonates (e.g., pamidronate, alendronate, or clodronate) for palliative intent or metastasis intervention
* At least 2 months since prior chronic non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2)-specific inhibitors (e.g., celecoxib or rofecoxib), administered for more than 7 days per month
* No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following:
* Phenytoin
* Fluvastatin
* Amiodarone
* Fluconazole
* Acenocoumarol
* Diclofenac
* No concurrent ketoconazole
* No concurrent antiretroviral therapy for HIV-positive patients
* Concurrent cardioprotective aspirin up to 100 mg once daily allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.