ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02757365
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Yang Lu, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: aspirin Drug: Levofloxacin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : April 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: the NSAIDs group
Patients in the this Group will received the aspirin 100mg qd until the experiment finished
Drug: aspirin
Experimental: the antibiotics group
Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks
Drug: Levofloxacin
Experimental: 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
Drug: aspirin Drug: Levofloxacin
No Intervention: the control group
No treatment



Primary Outcome Measures :
  1. prostate specific antigen(PSA,obtain from blood) [ Time Frame: 3 months ]
    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

  2. digital rectal examination [ Time Frame: 3 months ]
    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. ultrasound of the prostate [ Time Frame: 3 month ]
    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)

  4. biopsy of the prostate [ Time Frame: 3 month ]
    confirm the diagnosis;the type of prostate cancer;the classification of inflammation

  5. fPSA [ Time Frame: 3 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757365


Locations
China, Sichuan
West Hospital of China Recruiting
Chengdu, Sichuan, China, 610000
Contact: Qiang Wei, M.D    +86-18980601425    weiqiang933@126.com   
Sponsors and Collaborators
West China Hospital

Responsible Party: Yang Lu, Medical Doctor, West China Hospital
ClinicalTrials.gov Identifier: NCT02757365     History of Changes
Other Study ID Numbers: Huaxi
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Yang Lu, West China Hospital:
aspirin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Aspirin
Levofloxacin
Ofloxacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors