Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: aspirin; Drug: Levofloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West Hospital of China
      • Contact: Qiang Wei, M.D; Phone Number: +86-18980601425; Email: weiqiang933@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: aspirin
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Aspirin; Levofloxacin; Ofloxacin
• Other Study ID Numbers: Huaxi