None listed
Conditions
Interventions
Group 1 Type of group
Rofecoxib 25 mg PO daily until there is evidence of local / systemic prostate cancer, unacceptable toxicity or until the surveillance board decides to discontinue the study.
Group name:Group 2 Type of group
Placebo PO daily until there is evidence of local / systemic prostate cancer, unacceptable toxicity or until the surveillance board decides to discontinue the study.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient understands and is able to carry out the procedures and agrees to participate in the study by providing written informed consent. • The patient is male> 40 years of age who has undergone a radical prostatectomy with attempted healing of the histologically confirmed pathological condition T2 to T3a, NO, MO (Appendix 4) of an adenocarcinoma of the prostate. Patients may NOT have received complementary hormone therapy. • The patient has completed a surgical therapy within 12 weeks prior to the administration of the drug. • The patient has a Gleason score of 7 with positive surgical margins or a sum of Gleason Score 3> to 8 out of 10 with negative surgical margins. • The patient has an O-1 performance status in the GOCE. • The patient has a presurgical APE of> 4.0 mg / mL and has an APE of <0.2 mg / mL after radical prostatectomy and within 2 weeks prior to administration of the drug. • The patient after an appropriate clinical evaluation (which includes a previous bone scan and tests) has been ruled out of a diagnosis of recurrent prostate cancer.
Exclusion criteria
Exclusion criteria: • The patient is mentally or legally incapacitated at the time of the study or has a history (within 2 years prior to study entry) of alcohol or drug abuse or is a user (including recreational use) of an illicit drug. • The patient has a history of gastric, biliary or small bowel surgery that causes malabsorption. • The patient has a history of esophageal or gastric surgery or active gastrointestinal ulcer. (Patients with a history of simple perforation surgery greater than 3 months before the start of the study can participate in the study, and patients with a history of a simple hiatal hernia healed can participate in the study.) • The patient has a history of inflammatory bowel disease. • The patient has a history of liver disease / active hepatitis. • The patient has a history of hemorrhagic diathesis. • The patient suffers from uncontrolled hypertension. P ^ ota: patients suffering from medically controlled hypertension (diastolic blood pressure 9 gm / dL, bilirubin> 1.5 times the upper limit of normal, ALT or AST> 2 times the limit superior normal or cratinin> 1.5 times the upper limit of normal. • The patient uses NSAIDs or coxibs with or without a prescription (including CELEBRBX [celecoxib, Pfizer, Inc.], VIOXX) in chronic form (defined as> 7 days for one month before entry into the study). The use of NSAIDs, including CELEBREX ™ or VIOXX ™, at any time during the course of the test, is prohibited unless patients taking <100 mg / day of aspirin can be included in the study. Also, patients who have or develop the need to take cardioprotective doses of aspirin after randomization are allowed to use doses of <100 mg / day of aspirin. • The patient is allergic or hypersensitive (for example, bronchoconstriction in association with nasal polyps) to aspirin, naproxen or other NSAIDs. • The patient has undergone alternative therapies with hormonal effects (eg PC-SPES and / or medicinal herbs) 1 month before the administration of rofecoxib or placebo or plans to undergo alternative therapies with hormonal effects (eg PC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Recurrences defined by an elevated PSA of at least 0.2 mg / mL, occurring before the end of the study. Measure:Incidence of recurrent prostatic cancer Timepoints:before the end of the study. ; Outcome name:A secondary analysis will be carried out to calculate and compare the time elapsed until the recurrence defined by the PSA for each treatment group. Measure:Safety and general tolerability of the treatment Timepoints:At the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:recurrence is defined as: (i) some clinical recurrence (local and systemic) and (ii) all recurrences (local / systemic and PSA) Measure:Indexes of recurrence between groups Timepoints:During treatment ; Outcome name:Registry of effects of rofecoxib or placebo treatment on biochemical markers Measure:Effects of rofecoxib or placebo treatment on biochemical markers Timepoints:During treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed