2000 Participants Needed

Genomics for Prostate Cancer

Recruiting at 20 trial locations
KO
FH
Overseen ByFatima H Karzai, M.D.
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: National Cancer Institute (NCI)
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 aims to explore how specific gene mutations affect the progression and treatment response of prostate cancer. Researchers seek to identify additional gene mutations that might increase the risk or aggressiveness of the disease. Ideal participants are men diagnosed with prostate cancer who have certain gene mutations or those who have experienced a remarkable response to treatment, either achieving complete cancer elimination or long-term disease stability. Researchers will review participants' medical records and genetic information, and participants may be asked to provide blood, urine, or tumor samples for research. The study is conducted remotely, with follow-ups every six months to monitor health changes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in prostate cancer treatment.

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. It seems focused on collecting genetic and health data rather than altering your treatment.

What prior data suggests that this precision-based genomics method is safe?

Research has shown that using genes to guide treatment, known as precision genomics, is generally safe and well-tolerated. For instance, a study using a similar approach for another condition found it safe for participants, with most not experiencing serious side effects.

In precision genomics, doctors examine a patient's genes to determine the best treatment approach. This method helps select treatments that are more effective and have fewer side effects. The goal is to make treatment more personal and effective.

While specific data for prostate cancer is not yet available, precision genomics has been used safely in other studies. Every treatment carries some risks, but precision genomics aims to reduce these by tailoring care to each patient's unique genetic makeup.12345

Why are researchers excited about this trial?

Most treatments for prostate cancer, such as surgery, radiation, and hormone therapy, work by targeting and removing or suppressing cancer cells in the prostate. However, Precision-Based Genomics is unique because it customizes treatment based on a patient's specific genetic makeup. Researchers are excited about this approach because it aims to increase treatment effectiveness and minimize side effects by tailoring interventions to the individual's genetic profile, potentially leading to better outcomes and quality of life for patients.

What evidence suggests that precision-based genomics could be effective for prostate cancer?

Research has shown that using detailed genetic information can significantly improve patient outcomes. One study found that treatments tailored to a person’s genetic makeup improved outcomes by 85%. This method examines genetic changes to understand their impact on cancer growth and treatment response. By doing so, it customizes treatments to match an individual's cancer behavior. Using genetics in medicine represents a cutting-edge approach that could transform the treatment of diseases like prostate cancer.46789

Who Is on the Research Team?

FH

Fatima H Karzai, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects with histologically confirmed prostate cancer.
Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high([defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB [greater than or equal to 16 mut/Mb]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified)
OR be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Data Collection

Participants provide clinical information including medical history, clinical tests, imaging studies, surgical pathology reports, and genetic test results

Ongoing

Follow-up

Participants are monitored for patterns of disease recurrence and progression, response to therapies, and duration of responses

Lifetime
Contact every 6 months by phone or e-mail

What Are the Treatments Tested in This Trial?

Interventions

  • Precision-Based Genomics

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Genomics and multiomics in the age of precision medicine

Our review presents a broad perspective on the utility and feasibility of a genomics-first approach layered with other omics data.

A roadmap to precision medicine through post-genomic ...

Key outcomes from the network include the development of algorithms to extract computable phenotypes, or 'PheCodes' from EMR data (based on ICD ...

New Clinical Evidence Shows 85% Better Patient Outcomes

Personalized medicine has shown good progress, including 85% better patient outcomes through genomically-matched treatments, 76% response rates in CAR-T cell ...

The impact of genomics on precision public health: beyond ...

Genomic technologies have been at the leading edge of applications in clinical medicine and have the potential to revolutionize public health.

Towards precision medicine: Leading with big data and ...

Precision medicine relies on individuals' genetic information, omics characteristics, and environmental factors to achieve personalized disease prevention, ...

Precision BioSciences Presents Late-Breaking Phase 1 ...

Precision BioSciences Presents Late-Breaking Phase 1 PBGENE-HBV Data at AASLD The Liver Meeting® Showing Safety, Tolerability and Cumulative, ...

Precision public health in the era of genomics and big data

Precision public health (PPH) considers the interplay between genetics, lifestyle and the environment to improve disease prevention, diagnosis and treatment.

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precisiongenetics.com

precisiongenetics.com/

Precision Genetics | Science. Only Smarter.

Neuropharmagen helps providers identify safer and more effective medications for patients based on their genetics and other relevant factors.

It Is in Our DNA: Bringing Electronic Health Records and ...

This paper outlines the potential of genomic data integration with electronic records, and how these data can enable precision medicine.