A Phase 4 interventional study of aspirin and Levofloxacin in Prostate Cancer, sponsored by West China Hospital. Status unknown at 1 site in China. Open to male participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by West China Hospital · Phase 4, Interventional, and Prevention
Though the pathogenesis of prostate cancer (PCa) is still obscure, it has been reported, by investigators previous studies and some other researches, that PCa is often combined with tissue inflammation which is closely related to prostate specific antigen (PSA) level. Inflammation could play an important role in the process of occurrence and development of PCa, however the mechanism is unknown. Inflammatory cytokines could not only mediate inflammatory reactions, but also participate in the growth, proliferation, invasion and progression of tumor cells. It has been found that non-steroid anti-inflammatory drugs (NSAIDs), such as aspirin, can effectively prevent several inflammation related tumor, and coincidentally, PCa is also closely associated with inflammation. Moreover, latest researches demonstrated that hormone therapy could induce tissue inflammation in PCa, in which a large quantity of immune B cells were attracted into the focal and then a lot of cytokines, such as IKK-β, NF-κB, were released. These cytokines could inhibit apoptosis and promote the growth of tumor cells, which might be a possible mechanism for long-term inflammatory infiltration inducing the occurrence of PCa and the transformation to castration-resistant prostate cancer (CRPC). Based on these proofs, investigators presume it could be possibly an effective way to prevent the occurrence of PCa and the transformation from androgen-dependent prostate cancer to CRPC by means of long-term oral aspirin. In this study, investigators intend to explore the possible effect of anti-inflammatory therapy on the progress of transformations from inflammation to PCa and from androgen-dependent prostate cancer to CRPC. Investigators plan to conduct both clinical trials in four groups, including the control group, the NSAIDs group, the antibiotics group and the NSAIDs+antibiotics group, and a basic experiment in vitro to assess the effectiveness of anti-inflammatory drugs and elucidate the specific molecular mechanism.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
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Exclusion Criteria:
Patients in the this Group will received the aspirin 100mg qd until the experiment finished
Drug: aspirin
Patients in the this Group will received the Levofloxacin 0.5g qd for 4\~8 weeks
Drug: Levofloxacin
Patients in the this Group will received the Levofloxacin 0.5g qd for 4\~8 weeks and aspirin 100mg qd until the experiment finished
Drug: aspirin · Drug: Levofloxacin
No treatment
prostate specific antigen（PSA,obtain from blood）
Investigators use this index to screen the patient of prostate cancer.PSA is a reliable index to predict the occurrence of prostate cancer,if PSA\>10ng/ml,there is much evidence to suspect prostate cancer
Time frame: 3 months
digital rectal examination
Estimation of anal sphincter tone(mild;middle;tight,all the evaluation are reported by the same doctor by inserting index finger into anas to detect the sphincter tone)；prostate's the texture(hard;soft);weather there exist nodule on the prostate,diagnosed by touching the surface of the prostate)
Time frame: 3 months
ultrasound of the prostate
the size of prostate(size=0.52\* anteroposterior diameter\*Left and right diameter\*vertical diameter);the change of the findings(compared to the last ultrasound findings);calcification(dense echo)
Time frame: 3 month
biopsy of the prostate
confirm the diagnosis;the type of prostate cancer;the classification of inflammation
Time frame: 3 month
fPSA
a small part of total PSA;obtain from blood;Investigators use this index to screen the patient of prostate cancer.PSA is a reliable index to predict the occurrence of prostate cancer,if PSA\>10ng/ml,there is much evidence to suspect prostate cancer;If fPSA/PSA less than 10%,it is highly suspected being prostate cancer
Time frame: 3 months
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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West China Hospital