Clinical trial NCT02757365: Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: aspirin
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: prostate specific antigen（PSA,obtain from blood）
timeFrame: 3 months
measure: digital rectal examination
timeFrame: 3 months
measure: ultrasound of the prostate
timeFrame: 3 month
measure: biopsy of the prostate
timeFrame: 3 month
measure: fPSA
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West Hospital of China
state: Sichuan
Study officials:
References: