Genetic Testing for Prostate Cancer Recurrence

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Brachytherapy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best use of genetic testing to predict the recurrence of prostate cancer after surgery. Researchers will collect and analyze samples, such as tissue and blood, to identify biomarkers that might signal cancer's return. Men planning to undergo robotic prostate surgery at City of Hope, who have not received treatments like hormone therapy, qualify as good candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing neoadjuvant treatment with Androgen Deprivation Therapy (ADT), you would be excluded from the trial.

What prior data suggests that this genetic testing method is safe for predicting prostate cancer recurrence?

Research has shown that DNA methylation markers used in genetic tests for prostate cancer have been widely studied. Over 55 studies have examined these markers, enhancing the understanding of prostate cancer. The studies also focus on the safety of collecting samples like blood and tissue, which is common in medical research. Procedures such as drawing blood and taking tissue samples are usually well-tolerated by patients.

In this trial, researchers are collecting and analyzing these samples to find markers that might predict cancer recurrence. Since the trial is in its early stages, the main goal is to assess the safety of these procedures. Early-phase trials typically involve fewer participants and focus on evaluating safety and side effects. While the procedures are generally safe, the trial closely monitors for any side effects to ensure patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for prostate cancer recurrence focus on surgery, radiation, or hormone therapy. However, researchers are excited about the new protocol that utilizes genetic testing to predict cancer recurrence. This approach is unique because it leverages advanced techniques like DNA methylation analysis and gene expression analysis to provide a more personalized risk assessment. By examining molecular markers, it aims to identify patients at higher risk for recurrence more accurately and earlier than traditional methods. This could lead to more tailored and timely interventions, potentially improving outcomes and reducing unnecessary treatments.

What evidence suggests that this trial's treatments could be effective for predicting prostate cancer recurrence?

Research has shown that genetic testing can help predict the recurrence of prostate cancer. Studies have identified changes in DNA, specifically the attachment of small molecules called methyl groups, as a reliable indicator of prostate cancer. One study discovered that a test using a panel of six genes with these DNA changes accurately detected prostate cancer. It correctly identified cancer in 73 out of 100 patients who had it and correctly ruled it out in 76 out of 100 who didn’t. This trial will involve diagnostic laboratory biomarker analysis, including DNA methylation analysis, to further explore these findings. These results suggest that genetic testing, particularly focusing on these DNA changes, could be a powerful tool in predicting the return of prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Steven S. Smith, PhD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer scheduled for robotic surgery at City of Hope. It's not open to those who've had hormone therapy, salvage prostatectomy, or seed implant radiation before the surgery.

Inclusion Criteria

All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study

Exclusion Criteria

Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Assessment

Participants receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing.

1 day

1 visit (in-person)

Surgery and Intraoperative Assessment

On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.

1 day

1 visit (intraoperative)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic Laboratory Biomarker Analysis
• DNA Analysis
• DNA Methylation Analysis
• Gene Expression Analysis
• Polymerase Chain Reaction
• RNA Analysis
• Therapeutic Conventional Surgery

Trial Overview The study is testing how well genetic tests can predict cancer recurrence after prostate surgery. It involves analyzing patients' tissue, blood, and other fluids using various laboratory techniques like DNA/RNA analysis.

How Is the Trial Designed?

Group I: Diagnostic (specimen collection) Experimental Treatment 7 Interventions

Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Genetic and genomic testing for prostate cancer is advancing rapidly, with DNA damage response gene defects now recognized as key predictors for the effectiveness of FDA-approved treatments like PARP inhibitors and immune checkpoint inhibitors in metastatic cases.

New technologies, including RNA expression tests and circulating tumor DNA analysis, are enhancing patient risk assessment and treatment personalization, making genetic testing essential for managing prostate cancer effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic and Genomic Testing for Prostate Cancer: Beyond DNA Repair. Herberts, C., Wyatt, AW., Nguyen, PL., et al.[2023]

A study of 776 prostate cancer patients identified eight specific genetic variations (SNPs) that can predict the risk of biochemical recurrence after radical prostatectomy, enhancing the understanding of individual risk factors.

Incorporating these genetic variations into a clinical model improved the predictive accuracy of biochemical recurrence from 85.1% to 89.0%, demonstrating that personalized genetic information can significantly enhance patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome-wide detection of allelic genetic variation to predict biochemical recurrence after radical prostatectomy among prostate cancer patients using an exome SNP chip. Oh, JJ., Park, S., Lee, SE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7602626/

Advances in Prognostic Methylation Biomarkers for ... In this review, we provide a comprehensive overview of the current state of DNA methylation biomarker studies in prostate cancer prognosis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0959804922013089

Methylation biomarkers for early cancer detection and ... The proposed test uses a six-gene DNA methylation panel to detect prostate cancer from urine with a sensitivity and specificity of 73% and 76% when combined ...

3. activemotif.com activemotif.com/blog-dna-methylation-prostate-cancer

DNA Methylation for Predicting Prostate Cancer DNA Methylation Analysis as a Source of Biomarkers. Genome-wide Profiling of DNA Methylation in Prostate Cancer Patients - A Source of New ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5601644/

Promoter DNA methylation analysis reveals a combined ... Results revealed a novel potential biomarker for prostate cancer diagnosis. Keywords: prostate cancer, DNA methylation, promoter, diagnostic biomarker, gene ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2012.47.1847

DNA Methylation Signatures for Prediction of Biochemical ... Quantitative Methylation-Specific Polymerase Chain Reaction Gene Patterns in Urine Sediment Distinguish Prostate Cancer Patients From Control Subjects.

6. mdpi.com mdpi.com/2218-273X/15/9/1334

The Years 2015–2025 as a Prospective Decade for ... This re-analysis confirmed that all five genes displayed significantly higher methylation levels in prostate cancer samples compared to control samples [6].

7. mdxhealth.com mdxhealth.com/confirm-mdx-for-physicians/

Confirm mdx for Physicians DNA methylation biomarkers associated with prostate cancer have been extensively evaluated. More than 55 studies on the Confirm mdx genes and technology have ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6211380/

Molecular Biomarkers in the Clinical Management of Prostate ... We review the current state of the art regarding prostate cancer molecular biomarkers, emphasizing those with demonstrated utility in clinical practice.

9. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=16

LCD - Genetic Testing for Oncology (L39367) This LCD addresses testing of DNA and RNA in the context of oncology through the use of multiple evidence-based third-party databases and MAC review of ...