Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

NCT02757365 | Unknown Phase 4

• 1 other identifier: Huaxi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

aspirin

Outcome Measures

Primary Outcomes (5)

• 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

  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)

  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)

  3 month

• biopsy of the prostate

  confirm the diagnosis;the type of prostate cancer;the classification of inflammation

  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

  3 months

Study Arms (4)

the NSAIDs group

EXPERIMENTAL

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

Drug: aspirin

the antibiotics group

EXPERIMENTAL

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

Drug: Levofloxacin

the NSAIDs+antibiotics group

EXPERIMENTAL

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

the control group

NO INTERVENTION

No treatment

Interventions

aspirin DRUG

the NSAIDs group; the NSAIDs+antibiotics group

Levofloxacin DRUG

the NSAIDs+antibiotics group; the antibiotics group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West Hospital of China

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Levofloxacin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

CN (1)