Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
aspirin
Levofloxacin
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring aspirin
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
Sites / Locations
- West Hospital of ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
the NSAIDs group
the antibiotics group
the NSAIDs+antibiotics group
the control group
Arm Description
Patients in the this Group will received the aspirin 100mg qd until the experiment finished
Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks
Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks and aspirin 100mg qd until the experiment finished
No treatment
Outcomes
Primary Outcome Measures
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
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)
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)
biopsy of the prostate
confirm the diagnosis;the type of prostate cancer;the classification of inflammation
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02757365
Brief Title
Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
aspirin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the NSAIDs group
Arm Type
Experimental
Arm Description
Patients in the this Group will received the aspirin 100mg qd until the experiment finished
Arm Title
the antibiotics group
Arm Type
Experimental
Arm Description
Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks
Arm Title
the NSAIDs+antibiotics group
Arm Type
Experimental
Arm Description
Patients in the this Group will received the Levofloxacin 0.5g qd for 4~8 weeks and aspirin 100mg qd until the experiment finished
Arm Title
the control group
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Primary Outcome Measure Information:
Title
prostate specific antigen(PSA,obtain from blood)
Description
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
Time Frame
3 months
Title
digital rectal examination
Description
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)
Time Frame
3 months
Title
ultrasound of the prostate
Description
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)
Time Frame
3 month
Title
biopsy of the prostate
Description
confirm the diagnosis;the type of prostate cancer;the classification of inflammation
Time Frame
3 month
Title
fPSA
Description
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
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
West Hospital of China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Wei, M.D
Phone
+86-18980601425
Email
weiqiang933@126.com
12. IPD Sharing Statement
Learn more about this trial
Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer
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