Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02757365
Study type	Interventional
Source	West China Hospital
Contact
Status	Recruiting
Phase	Phase 4
Start date	April 2014
Completion date	April 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05540392` - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues	Phase 1/Phase 2
Recruiting	`NCT05613023` - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT	Phase 3
Recruiting	`NCT05156424` - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer	Phase 1/Phase 2
Completed	`NCT03177759` - Living With Prostate Cancer (LPC)
Completed	`NCT01331083` - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer	Phase 2
Recruiting	`NCT05540782` - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting	`NCT04742361` - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer	Phase 3
Completed	`NCT04400656` - PROState Pathway Embedded Comparative Trial
Completed	`NCT02282644` - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry	N/A
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT06305832` - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer	Phase 2
Recruiting	`NCT05761093` - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed	`NCT04838626` - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection	Phase 2/Phase 3
Recruiting	`NCT03101176` - Multiparametric Ultrasound Imaging in Prostate Cancer	N/A
Completed	`NCT03290417` - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer	N/A
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed	`NCT01497925` - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT03679819` - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed	`NCT03554317` - COMbination of Bipolar Androgen Therapy and Nivolumab	Phase 2
Completed	`NCT03271502` - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.