Genetic Testing for Prostate Cancer Screening
(ProGRESS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Prostate cancer, Prior biopsy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Prostate cancer is the most common non-skin cancer among Veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that healthcare providers screen male Veterans for prostate cancer.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Precision screening intervention for prostate cancer?
Research shows that using genetic information can help tailor prostate cancer screening to individual risk, potentially reducing unnecessary treatments and improving outcomes. Genetic tests can identify men with inherited mutations who may benefit more from specific treatments, making screening more precise and effective.
12345Is genetic testing for prostate cancer screening safe for humans?
The research does not provide specific safety data for genetic testing in prostate cancer screening, but it focuses on identifying genetic predispositions to improve screening strategies.
34678How is the Precision screening intervention treatment for prostate cancer unique?
The Precision screening intervention for prostate cancer is unique because it uses genetic testing to tailor screening strategies based on an individual's inherited risk, potentially reducing overdiagnosis and overtreatment compared to traditional methods like PSA (prostate-specific antigen) screening.
23579Eligibility Criteria
The ProGRESS study is for male Veterans aged 55-69 who regularly receive care from the VA. It's designed to help those at risk of prostate cancer and aims to reduce unnecessary biopsies in men with low risk by using genetic testing.Inclusion Criteria
Veteran status
Receipt of regular VA care
I am between 55 and 69 years old.
Exclusion Criteria
I carry a rare genetic variant linked to cancer.
I have had a prostate biopsy, surgery, or MRI before.
I have had prostate cancer in the past.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Proof-of-concept
Develop a precision prostate cancer screening intervention and determine feasibility of enrolling men aged 55-70 to a pragmatic RCT
Not specified
Clinical Trial
RCT comparing precision screening intervention to usual care, testing co-primary hypotheses regarding time-to-diagnosis and biopsy rates
7 years
Follow-up
Participants are monitored for safety and effectiveness after treatment, including prostate cancer diagnoses, PSA testing, and quality of life
7 years
Participant Groups
This trial tests a precision screening intervention based on genetic testing against usual care methods. The goal is to see if this new approach more accurately identifies men at high or low risk for significant prostate cancer.
2Treatment groups
Experimental Treatment
Group I: Usual careExperimental Treatment1 Intervention
Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.
Group II: Precision screening interventionExperimental Treatment2 Interventions
The precision screening intervention will consist of an interpreted prostate cancer genetic risk assessment (GRA) report, provided to the participant along with tailored prostate cancer screening recommendations and, in cases of high genetic risk, genetic counseling. The risk report and supporting educational materials will also be provided to the participant's primary care provider. Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, MA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Prostate Cancer Germline Variations and Implications for Screening and Treatment. [2021]Prostate cancer (PCa) is a highly heritable disease, and rapid evolution of sequencing technologies has enabled marked progression of our understanding of its genetic inheritance. A complex polygenic model that involves common low-penetrance susceptibility alleles causing individually small but cumulatively significant risk and rarer genetic variants causing greater risk represent the current most accepted model. Through genome-wide association studies, more than 100 single-nucleotide polymorphisms (SNPs) associated with PCa risk have been identified. Consistent reports have identified germline mutations in the genes BRCA1, BRCA2, MMR, HOXB13, CHEK2, and NBS1 as conferring moderate risks, with some leading to a more aggressive disease behavior. Considering this knowledge, several research strategies have been developed to determine whether targeted prostate screening using genetic information can overcome the limitations of population-based prostate-specific antigen (PSA) screening. Germline DNA-repair mutations are more frequent in men with metastatic disease than previously thought, and these patients have a more favorable response to therapy with poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors. Genomic information is a practical tool that has the potential to enable the concept of precision medicine to become a reality in all steps of PCa patient care.
Genetic and Genomic Testing for Prostate Cancer: Beyond DNA Repair. [2023]Significant progress has been made in genetic and genomic testing for prostate cancer across the disease spectrum. Molecular profiling is increasingly relevant for routine clinical management, fueled in part by advancements in testing technology and integration of biomarkers into clinical trials. In metastatic prostate cancer, defects in DNA damage response genes are now established predictors of benefit to US Food and Drug Administration-approved poly (ADP-ribose) polymerase inhibitors and immune checkpoint inhibitors, and trials are actively investigating these and other targeted treatment strategies in earlier disease states. Excitingly, opportunities for molecularly informed management beyond DNA damage response genes are also maturing. Germline genetic variants (eg, BRCA2 or MSH2/6) and polygenic germline risk scores are being investigated to inform cancer screening and active surveillance in at-risk carriers. RNA expression tests have recently gained traction in localized prostate cancer, enabling patient risk stratification and tailored treatment intensification via radiotherapy and/or androgen deprivation therapy for localized or salvage treatment. Finally, emerging minimally invasive circulating tumor DNA technology promises to enhance biomarker testing in advanced disease pending additional methodological and clinical validation. Collectively, genetic and genomic tests are rapidly becoming indispensable tools for informing the optimal clinical management of prostate cancer.
Genetically Informed Prostate Cancer Screening. [2021]Prostate cancer represents a significant health care burden in the United States due to its incidence, treatment-related morbidity, and cancer-specific mortality. The burden begins with prostate-specific antigen screening, which has been subject to controversy due to concerns of overdiagnosis and overtreatment. Advancements in molecular oncology have provided evidence for the inherited predisposition to prostate cancer, which could improve individualized, risk-adapted approaches to screening and mitigate the harms of routine screening. This review presents the current evidence for the genetic basis of prostate cancer and novel genetically informed, risk-adapted screening strategies for prostate cancer.
Diagnosing hereditary cancer predisposition in men with prostate cancer. [2022]We describe the pathogenic variant spectrum and identify predictors of positive results among men referred for clinical genetic testing for prostate cancer.
Prostate cancer gene test aids treatment precision. [2017]A simple test for men with advanced prostate cancer could identify those with an inherited gene mutation who would most benefit from precision treatments, new research suggests.
Targeted prostate cancer screening in men with mutations in BRCA1 and BRCA2 detects aggressive prostate cancer: preliminary analysis of the results of the IMPACT study. [2022]To evaluate the role of targeted prostate cancer screening in men with BRCA1 or BRCA2 mutations, an international study, IMPACT (Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted screening in BRCA1/2 mutation carriers and controls), was established. This is the first multicentre screening study targeted at men with a known genetic predisposition to prostate cancer. A preliminary analysis of the data is reported.
Initial Findings from a High Genetic Risk Prostate Cancer Clinic. [2022]To improve prostate cancer screening for high-risk men, we developed an early detection clinic for patients at high genetic risk of developing prostate cancer. Despite the rapidly growing understanding of germline variants in driving aggressive prostate cancer and the increased availability of genetic testing, there is little evidence surrounding how best to screen these men.
Recent Insights on Genetic Testing in Primary Prostate Cancer. [2021]Prostate cancer (PCa) is one of the most common cancers in developed countries. The results of large trials indicate that the proportion of PCa attributable to hereditary factors is as high as 15%, highlighting the importance of genetic testing. Despite improved understanding of the prevalence of pathogenic variants among men with PCa, it remains unclear which men will most benefit from genetic testing. In this review, we summarize recent evidence on genetic testing in primary PCa and its impact on routine clinical practice. We outline current guideline recommendations on genetic testing, most importantly, for mutations in BRCA1/2, MMR, CHEK2, PALB2, and HOXB13 genes, as well as various single nucleotide polymorphisms associated with an increased risk of developing PCa. The implementation of genetic testing in clinical practice, especially in young patients with aggressive tumors or those with positive family history, represents a new challenge for the coming years and will identify men with pathogenic variants who may benefit from early screening/intervention and specific therapeutic options.
Current and Future Applications Of Genetic Prostate Cancer Screening in the Urologic Clinic. [2015]The limitations of PSA and DRE screening for prostate cancer have prompted much research into genetic-based screenings. This survey of innovations and obstacles in genomic testing will help prepare urologic clinicians for future interventions.