Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

NCT ID: NCT02757365

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-04-30

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the NSAIDs group

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

Group Type: EXPERIMENTAL

aspirin

Intervention Type: DRUG

the antibiotics group

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

Group Type: EXPERIMENTAL

Levofloxacin

Intervention Type: DRUG

the NSAIDs+antibiotics group

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

Group Type: EXPERIMENTAL

aspirin

Intervention Type: DRUG

Levofloxacin

Intervention Type: DRUG

the control group

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aspirin

Intervention Type: DRUG

Levofloxacin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Lu

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West Hospital of China

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiang Wei, M.D

Role: primary

weiqiang933@126.com

+86-18980601425

Other Identifiers

Huaxi

Identifier Type: -

Identifier Source: org_study_id