Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

Sichuan University

Status and phase: Unknown; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: aspirin; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02757365

Huaxi

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate Specific Antigen(PSA)>10ng/ml
• Suspected of Prostate Cancer
• Prostate Biopsy showed Benign Prostate Hyperplasia with infiltrated with lymphocytes

Exclusion criteria

• Serious Complication:heart disease;respiratory disease;blood disease;
• refused to join the trial
• Disease of hemorrhagic tendency

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

the NSAIDs group

Experimental group

Description:

Patients in the this Group will received the aspirin 100mg qd until the experiment finished

Treatment:

Drug: aspirin

the antibiotics group

Experimental group

Description:

Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks

Treatment:

Drug: Levofloxacin

the NSAIDs+antibiotics group

Experimental group

Description:

Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks and aspirin 100mg qd until the experiment finished

Treatment:

Drug: Levofloxacin

Drug: aspirin

the control group

No Intervention group

Description:

No treatment