500 Participants Needed

Genetic Testing for Prostate Cancer

(PROMISE Trial)

Recruiting at 2 trial locations
JV
Overseen ByJacob Vinson
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Prostate Cancer Clinical Trials Consortium
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on building a large database of prostate cancer patients with specific genetic changes known as germline pathogenic variants. The researchers aim to understand how these genetic changes affect patient outcomes and treatment success. Participants will provide a saliva sample for genetic testing and share their health and family history. Patients with a confirmed prostate cancer diagnosis—through biopsy, high PSA levels, or disease evidence on scans—and residing in the U.S. or its territories, are welcome to join. This trial connects participants with new research and treatment opportunities based on their genetic information. As an unphased study, it offers participants a unique chance to contribute to groundbreaking research that could lead to personalized treatment options.

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 seems focused on genetic testing and data collection rather than altering treatment plans.

What prior data suggests that this genetic testing protocol is safe?

Research has shown that the PROMISE Registry provides a safe method for learning more about prostate cancer and genetic risks. Participants provide a saliva sample for genetic testing, a simple and low-risk process. The main goal is to gather information and track health over time. The registry does not involve any treatments or drugs. Instead, it connects patients with potential clinical trials based on their genetic information. As the registry focuses on data collection rather than administering new treatments, participation carries no direct risk.12345

Why are researchers excited about this trial?

Researchers are excited about the PROMISE Registry because it aims to uncover how specific genetic mutations in prostate cancer patients affect treatment success and survival rates. Unlike typical treatments that focus solely on targeting cancer cells, this registry is exploring the genetic makeup of individuals to personalize treatment strategies. By understanding the unique germline mutations present in each patient, there's potential to tailor treatments more effectively, leading to improved outcomes compared to the one-size-fits-all approach of traditional therapies. This method could pave the way for more precise and successful treatments in the future.

What evidence suggests that the PROMISE Registry could be effective for prostate cancer patients?

Research has shown that genetic differences can greatly affect how prostate cancer patients respond to treatment. The PROMISE Registry, a nationwide study, aims to understand how these genetic differences influence treatment success and survival rates. Participants in this trial will be grouped based on their genetic profiles: one group will include those with at least one variant of uncertain significance, and another group will include those with at least one germline pathogenic or likely pathogenic variant. Early results suggest that certain inherited genetic changes can affect treatment response. By studying these changes, researchers aim to customize treatments for greater effectiveness. This registry will gather long-term data to identify the best treatment options for patients with specific genetic profiles.12346

Who Is on the Research Team?

HC

Heather Cheng, MD, PhD

Principal Investigator

Fred Hutchinson Cancer Center

CP

Channing Paller, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

Inclusion Criteria

tissue biopsy, and/or PSA greater than 100 ng/dL (1ng/ml), and/or clear radiographic evidence of disease
Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 years
Initial visit for saliva sample collection

Genetic Counseling

Participants with identified pathogenic variants meet with a genetic counselor to discuss results

1 visit
1 visit (in-person or virtual)

Follow-up

Participants are monitored every 6 months to obtain updated health records and patient-reported outcomes data

15 years
Bi-annual follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • PROMISE Registry
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Participants with at least one variant of uncertain significanceExperimental Treatment3 Interventions
Group II: Participants with at least one germline pathogenic/likely pathogenic variantExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prostate Cancer Clinical Trials Consortium

Lead Sponsor

Trials
12
Recruited
7,400+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials
1,998
Recruited
602,000+

Fred Hutchinson Cancer Center

Collaborator

Trials
583
Recruited
1,341,000+

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator

Trials
578
Recruited
33,600+

Advancing Cancer Treatment, Inc.

Collaborator

Trials
1
Recruited
500+

Citations

1.prostatecancerpromise.orgprostatecancerpromise.org/
Prostate Cancer Promise – In The Fight Against Prostate ...PROMISE is a registry of prostate cancer patients participating in a research study to learn how genetic differences can affect patient outcomes.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37964482/
A prostate cancer registry of outcomes and germline ...The PROMISE Registry is a novel, prospective, germline registry that will collect long-term patient outcomes data to address current gaps in ...
A Prostate Cancer Registry of Outcomes and Germline ...The PROMISE team is studying how these germline mutations affect treatment options and patient outcomes.
NCT04995198 | PROMISE Registry: A Prostate Cancer ...Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes ...
A prostate cancer registry of outcomes and germline ...PROMISE Registry: A prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness. Channing Judith Paller et al.
A prostate cancer registry of outcomes and germline ...PROMISE Registry: A prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness. Authors: Channing Judith ...
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