DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine

Prostate Adenocarcinoma Clinical Trial

Official title:

DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06347809
• Other study ID #: 18-006343
• Secondary ID: NCI-2024-0122518
• Status: Enrolling by invitation
• Start date: November 7, 2018
• Est. completion date: February 1, 2029

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests.

Description:

PRIMARY OBJECTIVE:

I. To assess the accuracy of MDM candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of CAP.

OUTLINE: This is an observational study.

PHASE I: Participants undergo urine sample collection on study.

PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study.

All participants complete a questionnaire and have their medical records reviewed on study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• * Patient is 18 years or older

• Patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated Prostate Specific Antigen (PSA), palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity

Exclusion Criteria:

• * Patient has had a transplant prior to sample collection

• Patient has had Androgen (e.g. Flutamide, Androcur, Casodex, Nilandron) or Luteinizing hormone-releasing hormone (LHRH) (e.g. Lupron, Zoladex) therapy

• Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection

• Patient has chronic indwelling urinary catheter

• Patient has had a urinary tract infection within the 14 days prior to sample collection

• Patient has immunotherapy (e.g. Kwon study drugs) for prostate cancer prior to sample collection

• Patient has a history of bladder cancer

• Patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection

• Patient has had surgery to completely remove current target pathology prior to sample collection

• Patient has a prior history of prostate carcinoma/adenocarcinoma

• Patient has received chemotherapy class drugs (e.g. Docetaxel, Methotrexate) within the 5 years prior to sample collection

• Patient has received therapeutic radiation prior to sample collection

• Patient has had focal ablation [e.g. High-intensity focused ultrasound (HIFU) or cryoablation] of prostate cancer prior to sample collection

• Patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Carcinoma

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)	Assessed by instances of CAP detected using MDMs assayed from urine (Phase I) and from urine and prostate fluid (collected following digital prostate massage for participants in Phase II) for detection of CAP.	Baseline
Secondary	Accuracy of CAP detection	Assessed by instances of CAP detected and confirmed using MDMs assayed from urine and prostate fluid.	Baseline
Secondary	Comparison of sample volumes	Variability of sample volumes will be assessed for DNA and MDM yield.	Baseline