Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Inflammation

Prostatitis

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Naproxen

Ibuprofen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Repeat PSA test at 6 (± 1) weeks, without any treatment

Treatment with NSAIDS (Ibuprofen 400 mg, 3 times per day or Naproxen 220 mg, twice per day for 10 days), then repeat PSA test at 6 (± 1) weeks

Participants will receive either Ibuprofen 400 mg 3 times per day or Naproxen 220 mg, twice per day for 10 days.

Ibuprofen or Naproxen

PSA test

Brenda Romeo

Badar M. Mian, MD

Badar Mian, MD

Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \> 90% of cases. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.

It's known that PSA level can be elevated due to reasons other than prostate cancer including benign prostatic hypertrophy, prostatitis or other urinary tract infections, non-infectious inflammation, and physiologic variation over time. Consequently, nearly 50% of prostate biopsy procedures performed due to elevated PSA level do not yield any cancer , but still expose the patients to the risks of the procedure related complications (discomfort/pain, anxiety, bleeding, infection, and cost). Thus, measures to improve the reliability of PSA test, and potentially avoiding unnecessary procedures, are of significant importance to the patient and healthcare system.

It is common practice to check PSA level annually. PSA test results can vary over time, either due to the imprecision in the analysis and/or due to the biologic variability. This can result in an apparent rise in PSA level when no clinically meaningful rise had occurred. Its estimated that the average lab variation in PSA was approximately 6% and the average biologic variation about 14%. This, it is recommended that isolated elevation in PSA level should be confirmed after several weeks, and before proceeding with further interventions, including prostate biopsy.

Sub-clinical, histologic Inflammation (presence of inflammatory cells) within the prostate tissue and its effect on PSA level has been reported in various settings. In two population-based studies, men who were regularly using over the counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs, e.g ibuprofen, naproxen) had lower PSA levels compared to non-users.

Currently, two strategies are utilized in clinical practice to ensure that the PSA level is truly elevated:

1. Repeat PSA test after several weeks or
2. A short course of OTC NSAIDs, and then repeat PSA test

Investigators propose to conduct a randomized study to determine the effect of NSAIDs on PSA level compared to the biologic variations in PSA level noted upon repeat testing.

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

Difference in PSA, within and between groups

To determine if changes in PSA level were sufficient to avoid intervention

To determine if the PSA changes correlate with the cancer diagnosis

Serial PSA levels will be examined to determine whether the change in PSA level is transient or durable

Patient reported symptom score, ranging from 0-35 (higher score=worse outcome)

Albany Medical College

Professor of Urology

Genital Neoplasms, Male

Urogenital Neoplasms

The Prostate Cancer Genius app includes the following components: (1) educational content that is consistent with existing evidence and recommendations for prostate cancer and prostate cancer screening but has been adapted for the African American male population and for adults who read at or below the 8th-grade level; (2) real-time messages about the risks of prostate cancer and the benefits of completing a PSA test, placing a special emphasis on screening considerations for individuals with a family history of prostate cancer and/or lower urinary tract symptoms (measured via the American Urological Association Symptom Score); (3) general trivia that also incorporates quiz questions about prostate cancer and the PSA test; (4) African American-specific testimonials and educational videos; (5) optional counseling by African American prostate cancer survivors; and (6) on-demand, automated ordering of a home-based PSA test.

The Prevention Taskforce app provides on-demand access to evidence-based recommendations for prostate cancer for men between 55 and 69 (i.e., it can be accessed as needed).

Participants assigned to use the Prostate Cancer Genius App will receive a combination of (a) scheduled and (b) on-demand content prostate cancer for one month. Scheduled content will be delivered on specific days each week using app notifications. Participants will also receive tailored navigation for ordering a home-based PSA kit, including receiving follow-up information from trained medical professionals about their test results.

Prostate Cancer Genius App

Participants assigned to use the US Prevention Task Force app will download the app from Google Play and will be instructed to use the app for one-month to to become more informed about prostate cancer. They will also be instructed to download a companion app from the Google Play store. This companion app will be used to deliver weekly assessments and order a home-based PSA test kit if the participant chooses to so. Participants assigned to the Prevention Taskforce app will receive a brochure providing details about the purpose of the home-based PSA test.

US Prevention Taskforce App

Adam C Alexander, PhD

Ashley Krukowski, MPA, CRA

Adam Alexander, PhD

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. To address this inequity, innovative team science approaches are required. This project proposes to develop and test the first-of-its-kind Prostate Cancer Genius App to improve knowledge of prostate cancer risk and symptoms, and deliver tailored navigation to complete a home-based PSA test. The primary goal of this study is to evaluate the feasibility of the Prostate Cancer Genius App in a 30-day pilot randomized control trial compared to an existing app developed by the U.S. Department of Health \& Human Services (Prevention Taskforce App). African American men from Oklahoma, aged between 55 and 69 (N = 80), eligible for the PSA test will be randomly assigned 1:1 to receive either app. Three dimensions of app feasibility will be assessed: (1) preliminary efficacy, evaluated via post-intervention differences in prostate cancer knowledge, (2) app engagement and accessibility, measured via self-report questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. Finally, the investigative team will explore post-intervention PSA screening rates and identify predictors of screening/not screening across both arms. The successful demonstration of feasibility for the Prostate Cancer Genius App within Oklahoma will support expanding this intervention to African Americans nationwide.

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. Disparities in prostate cancer for African American men have persisted for almost half a century, and these health disparities are among the most extreme of all cancers in the United States. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. The process of informed and effective decision-making is heavily underpinned by adequate knowledge levels of the disease and screening benefits and risks, with lower knowledge levels reported among African American men. This project will test the feasibility of a first-of-its-kind Prostate Cancer Genius App (herein referred to as Genius App) to improve knowledge of prostate cancer risk and symptoms. PSA testing is not appropriate for all men, so the Genius App will support informed decision-making with a healthcare provider. The Genius App will also provide novel tailored navigation to complete a home-based PSA test for men who opt to screen. To test the app, 80 African American men from Oklahoma (aged 55 and 69) who are not up to date with PSA screening will be randomly assigned 1:1 to use either the Genius app or an existing U.S. Department of Health \& Human Services app (herein referred to as the Prevention Taskforce App) for 30 days.

Aim 1. Evaluate the preliminary efficacy of a prostate cancer prevention app on prostate cancer knowledge (primary outcome).

Hypothesis: Participants (n = 40) randomly assigned to the Genius app will report significantly greater knowledge about prostate cancer post-intervention than participants (n = 40) randomly assigned to the Prevention Taskforce‬ app at 30 days post-randomization.

Aim 2. Explore the perceived engagement, accessibility, and acceptability of a prostate cancer prevention app.

The investigative team will explore: (i) the extent to which participants find the Genius App engaging and accessible compared to the Prevention Taskforce‬ app via validated self-report questionnaires and app metadata; and (ii) the perceived acceptability of the Genius App by conducting semi-structured interviews (n=40) with participants to acquire in-depth descriptions of their experiences with the app at the end of the study.

Aim 3. Derive preliminary estimates of the effects of a Genius App on PSA screening test completion rates and identify mechanisms of screening adherence.

The investigative team will (i) explore differences in PSA test completion rates, including in-clinic and home-based PSA testing, between the Genius app and the Prevention Taskforce‬ app and (ii) identify whether changes in key variables in weekly smartphone assessments predict completing a PSA test.

Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men

A Pilot Randomized Clinical Trial of a Smartphone-based Application for Prostate Cancer Education and Home-based PSA Screening for African American Men

All participants will complete a baseline survey and a post-intervention survey via REDCap. Baseline and post-intervention assessments will measure prostate cancer risk and screening knowledge using the Prostate Cancer Knowledge Scale.The scale consists of 18 items that assess screening (6 items), risk factors (5 items), and warning signs (7 items) of prostate cancer. This scale has strong internal consistency (α = .80) and has been validated for use in the African American population.

Home-based PSA test completion rates will be analyzed four weeks after enrollment via documented receipt of the kit. We will also measure the number of participants who (a) scheduled a visit with their provider, (b) reported shared decision making with their provider, and (c) self-report completing a clinic-based PSA test. To verify, participants will have the option to upload a copy of their results to verify self-report data.

University of Oklahoma

At least 40 SNP (single nucleotide polymorphisms)increase the risk of PCa. The individual risk of PCa accumulates with the increasing number of these genetic variants. The risk is doubled if patient has familial disposition as well. In retrospective studies, non-genetic risk-prediction models were compared to risk-prediction models containing both non-genetic factors and SNPs analyses. The genetic models had a significantly higher specificity than the non-genetic models. It has been argued that genetic PCa risk assessment could reduce the inexpedient use of PSA tests, saving it for patients at high risk of PCa.

Genetic risk assessment

Karina D Sørensen, PhD

Flemming Bro, Professor

Peter Vedsted, Professor

The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.

The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Prostate Cancer Risk Assessment Using Genetic Markers in General Practice

The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice.

Velux Fonden

Aarhus University Hospital

University of Aarhus

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

Do not carry a mutation in either the BRCA1 or 2 genes that has been found in other members of the family.

Patients tested for their level of Prostate Specific Antigen.

A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.

Prostate Biopsy

Rosalind A Eeles, FRCP FRCR

The IMPACT study is an international targeted prostate screening study of men at increased prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2 genes.

There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research has shown that these men are at an increased risk of developing prostate cancer but more information is needed about the pathogenesis of prostate cancer in this defined group and the role of screening in these men. The study will offer annual PSA screening to these men to determine the incidence of prostate cancer in this group. The study will also look at new markers of early prostate cancer in this cohort.

The power calculations for this study are 850 carriers and 850 controls (age-matched men without BRCA1/2 mutations). It is therefore essential to gain international collaboration to meet the target of recruiting 850 men with these known mutations and a control group of 850 men who have tested negative for a known familial mutation.

Prostate cancer is a significant public health problem. In the EU approximately 200,000 men are diagnosed annually with prostate cancer. There are 24,000 cases per year in England and Wales and 10,000 deaths. The incidence is increasing, even when screen-detected cancers are considered, and within the next few years it will become the most common cancer in UK men.

that an alteration in the breast cancer predisposition genes BRCA1 and BRCA2, may predispose to prostate cancer (PC) and this study will increase this evidence-base. There is some evidence, at least in BRCA2 carriers, that the prostate cancer in these men may be more aggressive and so earlier detection could theoretically reduce mortality. It has been reported that unaffected individuals from families with multiple cases of PC show an increased percentage of raised PSA levels, but the use of PSA level and its predictive value in healthy males with BRCA1/2 mutations has not been studied. If PSA were to be used as a screening tool in BRCA1/2 mutation carriers, we would need to gain a better understanding of the pathogenesis of PC in these men and determine whether they have a different baseline PSA profile compared with controls.

The high prevalence of hormone-dependent/secreting tumours such as breast, ovary and prostate in BRCA1/2 carriers suggests an important role of hormones and their receptors in the development of cancer. Androgens and androgen receptors are considered crucial elements in PC pathogenesis. Therefore male sex hormones will be measured to determine the hormone profile in BRCA1/2 carriers compared with a control group. There is strong evidence that BRCA1/2 play an important role in DNA repair and cell cycling. Therefore, we will investigate abnormalities of the metabolic processes in individuals with a BRCA1/2 mutation where cell cycling may be abnormal. Analysis of proteins (proteomics) and metabolites (metabonomics) are powerful approaches to identifying proteins and metabolites involved in cancer formation. The analysis of the proteins and metabolites will enable us to investigate the effect of the presence of a BRCA1/2 mutation and aid in the identification of new biomarkers for prostate cancer.

The target population is a group of 850 males who carry a known pathogenic mutation in the BRCA1/2 genes (500 BRCA1 and 350 BRCA2). These men will be recruited through genetics clinics across the UK and the world. A control group of men who have tested negative for a known pathogenic mutation that is running in their family will also be recruited through the genetics clinics.

All participants will be invited to attend annually for 5 years for an appointment lasting approximately 30 minutes during which they will discuss the study in detail before giving their written consent agreeing to participate. They will have a 50ml blood sample taken and be asked to provide a urine sample every year. They will also be required to complete a short family and medical history questionnaire. These appointments will either take place at the centre they are registered at, at the Royal Marsden Hospital, or in their own home depending on the arrangements made with the collaborating consultant and patient preference.

The PSA level of all participants will be measured locally. If PSA is \>3.0ng/ml, a ten core prostatic biopsy will be offered, carried out by a consultant urologist. Ten biopsies will be used for diagnostic purposes, with two extra biopsy samples taken for research analysis with the patients fully informed written consent prior to the procedure being carried out. If any of the ten cores identify the presence of prostate cancer, they will receive treatment for this as advised by their local centre. The PSA will be quality controlled by batch testing at a reference lab. If the value locally was \<3.0ng/ml but is \>3ng/ml in the reference lab it will be remeasured locally.

If high grade Prostatic Intraepithelial Neoplasia (PIN) is detected or if the sample is inconclusive then a sextant biopsy repeated after 6 weeks will be recommended, in accordance with the ERSPC protocol. If atypical acini are detected then immediate biopsy will be undertaken.

Whole blood, Serum, Plasma, Urine, Prostate tissue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test	NCT05629494	Prostate Cancer Prostate Inflam... PSA	Ibuprofen or Na... PSA test	18 Years - 80 Years	Albany Medical College
Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men	NCT05331638	Prostate Cancer Health Behavior	Prostate Cancer... US Prevention T...	55 Years - 69 Years	University of Oklahoma
Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men	NCT05331638	Prostate Cancer Health Behavior	Prostate Cancer... US Prevention T...	55 Years - 69 Years	University of Oklahoma
The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice	NCT01739062	Prostate Cancer	Genetic risk as...	18 Years - 80 Years	University of Aarhus
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer	NCT00261456	Prostate Cancer...	PSA test Prostate Biopsy	40 Years - 69 Years	Institute of Cancer Research, United Kingdom

Spots Global Cancer Trial Database for psa test

Every month we try and update this database with for psa test cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for psa test

Every month we try and update this database with for psa test cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for psa test cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.