Screening for Prostate Cancer

Recruiting at 6 trial locations

Overseen By Study Team Coordinator

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Prostate cancer, Recent cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to detect prostate cancer early in individuals at genetic risk for aggressive forms of the disease. Researchers will analyze blood, urine, and tissue samples to gain insights into the genetics of prostate cancer. This research could lead to improved methods for early detection and treatment in the future. Individuals with a prostate, over 40, and with a known genetic risk for prostate cancer might be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could enhance early detection strategies for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this screening method is safe?

Research has shown that collecting samples such as blood, urine, and tissue is a common and safe practice in medical studies. These samples help researchers understand diseases better. Past studies have not shown direct evidence of harm from taking these samples. Participants typically manage this process well. However, as with any medical procedure, minor discomfort may occur, such as a small bruise from a blood draw. Overall, previous studies have demonstrated that collecting these samples is low-risk and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding prostate cancer screening for people with a genetic risk for aggressive disease. Unlike standard screening methods that are typically based on general risk factors like age or PSA levels, this trial uses biospecimen collection, such as blood, urine, and tissue samples, to potentially identify specific biomarkers linked to genetic risk. This approach could lead to more personalized and precise screening methods, allowing for earlier detection and tailored treatment strategies for those at higher genetic risk.

What evidence suggests that this trial's methods could be effective for early detection of aggressive prostate cancer?

Research shows that collecting samples such as blood and urine can aid in understanding and detecting prostate cancer earlier. For example, the PLCO Cancer Screening Trial collected extensive data and samples to study cancer development and progression. In this trial, participants undergo biospecimen collection, which helps scientists identify genetic markers and other early signs of aggressive prostate cancer. Although this trial does not treat cancer directly, it aims to enhance future detection and treatment methods. Studying the genetics of cancer through these samples may lead to earlier and more effective interventions. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather H. Cheng, MD, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Inclusion Criteria

People with prostates ≥40 years of age

Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biospecimen Collection

Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after completion of curative therapy

Up to 3 years

Every 6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Laboratory Biomarker Analysis
• Questionnaire Administration

How Is the Trial Designed?

Group I: Screening (biospecimen collection) Experimental Treatment 4 Interventions

Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

CureBRCA

Collaborator

Trials

1

Recruited

450+

Canary Foundation

Collaborator

Trials

5

Recruited

4,700+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK51331/table/results.tu1/

Future Research Needs for Comparative Effectiveness ... Design: Establish biospecimen repositories with clinical data on diagnosis, treatment, and follow-up ; Population: Patients with localized prostate cancer ...

2. prevention.cancer.gov prevention.cancer.gov/news-and-events/blog/landmark-plco-cancer-screening-trial-leaves-legacy-through-data

Landmark PLCO Cancer Screening Trial Leaves Legacy ... This is due to the large resource of data and biospecimens that the study collected from participants over the course of the trial and beyond.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.30474

Extended mortality results for prostate cancer screening in the ... 16 Deaths from prostate cancer over a median 10 years of follow-up were very low in each arm, at most 1.5%, and no significant difference was ...

4. medicaljournalssweden.se medicaljournalssweden.se/actaoncologica/article/view/32233/37141

View of The Prostate, Lung, Colorectal and Ovarian Cancer ... Pros-tate cancer screening was with annual PSA testing for six years (T0 – T5) and digital rectal examination (DRE) annually for four years (T0 – T3). The ...

5. academic.oup.com academic.oup.com/ije/article-abstract/54/5/dyaf161/8257803

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer ... To assess screening, the trial collected data on screening outcomes, diagnostic examinations, cancer incidence, and mortality, including all ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4154946/

Biospecimens, biobanking and global cancer research ... An overview of biobanking and biospecimen repositories, and materials transfer in global prostate cancer collaborations were discussed.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05129605?term=prostate%20cancer&viewType=Table&rank=9

Study Details | NCT05129605 | Prostate Cancer Genetic ... Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance ...

8. prevention.cancer.gov prevention.cancer.gov/research-areas/networks-consortia-programs/plco

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer ... Prostate: After 13 years of follow-up, there was no evidence of a mortality benefit for organized annual screening compared with opportunistic screening, which ...

9. cancer.org cancer.org/research/population-science/study-and-biospecimens-team-and-analyst-core.html

Study and Biospecimen Team and Analyst Core Collect cancer outcomes' data about our cohort participants from state cancer registries and mortality data about participants from the National Death Index.

10. law.stanford.edu law.stanford.edu/publications/managing-global-biospecimen-and-data-collection-placement-programs/dehayes/

Managing Global Biospecimen and Data Collection & ... In order to locate biospecimens presenting adequate tumor percentage and homogeneity, a researcher may examine regions or countries where radical prostatectomy.