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

1045 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer

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 data supports the effectiveness of this treatment for prostate cancer recurrence?

Research shows that combining DNA methylation markers with PSA levels can help predict prostate cancer recurrence and guide treatment decisions more effectively than PSA alone. This approach may improve patient management by identifying those who might benefit from additional therapies after surgery. ^{1 2 3 4 5}

Is genetic testing for prostate cancer recurrence safe for humans?

Genetic and genomic testing for prostate cancer, including DNA and RNA analysis, is generally considered safe for humans. These tests are non-invasive and involve analyzing genetic material to help guide treatment decisions. ^{5 6 7 8 9}

How is the treatment for prostate cancer recurrence using genetic testing different from other treatments?

This treatment is unique because it uses advanced genetic and genomic testing to predict prostate cancer recurrence, allowing for personalized treatment plans. It involves analyzing DNA and RNA to identify specific genetic markers, which can help tailor therapies like surgery or radiotherapy to the patient's individual risk profile. ^{4 9 10 11 12}

Research Team

Steven S. Smith, PhD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Molecular biomarkers and prognostic factors for prostate cancer]. [2018]

2. Brazil pubmed.ncbi.nlm.nih.gov

Controversial predictors of biochemical recurrence after radical prostatectomy: a study from a Latin American (Brazilian) institution. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Two-stage classifiers that minimize PCA3 and the PSA proteolytic activity testing in the prediction of prostate cancer recurrence after radical prostatectomy. [2018]

4. Germany 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Methylation Markers in Prostate Biopsies Are Prognosticators for Late Biochemical Recurrence and Therapy after Surgery in Prostate Cancer Patients. [2021]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Genomic Profiling of Prostate Cancer: An Updated Review. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Signature Panel of 11 Methylated mRNAs and 3 Methylated lncRNAs for Prediction of Recurrence-Free Survival in Prostate Cancer Patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Genetic and Genomic Testing for Prostate Cancer: Beyond DNA Repair. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Discovery and validation of 3 novel DNA methylation markers of prostate cancer prognosis. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

DNA methylation screening of primary prostate tumors identifies SRD5A2 and CYP11A1 as candidate markers for assessing risk of biochemical recurrence. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Biopsy-based 17-gene Genomic Prostate Score as a Predictor of Metastases and Prostate Cancer Death in Surgically Treated Men with Clinically Localized Disease. [2018]