- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347809
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational
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. |
Non-Interventional Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of CAP detection
Time Frame: Baseline
|
Assessed by instances of CAP detected and confirmed using MDMs assayed from urine and prostate fluid.
|
Baseline
|
Comparison of sample volumes
Time Frame: Baseline
|
Variability of sample volumes will be assessed for DNA and MDM yield.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John B. Kisiel, M.D., Mayo Clinic in Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-006343 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2024-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Adenocarcinoma
-
Case Comprehensive Cancer CenterTerminatedAdenocarcinoma of Prostate | Adenocarcinoma of the Prostate Stage I | Adenocarcinoma of the Prostate Stage II | Adenocarcinoma of the Prostate Stage IIIUnited States
-
NRG OncologyNational Cancer Institute (NCI)Active, not recruitingStage II Prostate Adenocarcinoma | Stage III Prostate Adenocarcinoma | Stage I Prostate AdenocarcinomaUnited States, Canada, Puerto Rico
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedStage II Prostate Adenocarcinoma | Stage III Prostate Adenocarcinoma | Stage I Prostate AdenocarcinomaUnited States
-
Dana-Farber Cancer InstituteCompletedProstate Cancer | Adenocarcinoma of the Prostate Stage I | Adenocarcinoma of the Prostate Stage II | Adenocarcinoma of the Prostate Stage IIIUnited States
-
University of California, San FranciscoCompletedProstate Adenocarcinoma | Recurrent Prostate Carcinoma | Stage III Prostate Adenocarcinoma AJCC v7 | Stage I Prostate Adenocarcinoma AJCC v7 | Stage II Prostate Adenocarcinoma AJCC v7United States
-
National Cancer Institute (NCI)Active, not recruitingCastration-Resistant Prostate Carcinoma | Metastatic Prostate Carcinoma | Stage IV Prostate Adenocarcinoma AJCC v7 | Advanced Prostate Adenocarcinoma With Neuroendocrine Differentiation | Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation | Prostate Adenocarcinoma With Neuroendocrine...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage II Prostate Adenocarcinoma | Stage I Prostate Adenocarcinoma
-
NRG OncologyNational Cancer Institute (NCI)Active, not recruitingProstate Adenocarcinoma | Stage II Prostate Adenocarcinoma | Stage III Prostate Adenocarcinoma | Stage I Prostate AdenocarcinomaUnited States, Canada, Switzerland
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage III Prostate Adenocarcinoma AJCC v7 | Stage II Prostate Adenocarcinoma AJCC v7 | Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7United States
-
Andrei IagaruCompletedStage II Prostate Adenocarcinoma | Stage III Prostate Adenocarcinoma | Stage IV Prostate AdenocarcinomaUnited States
Clinical Trials on Non-Interventional Study
-
Universitätsklinikum Hamburg-EppendorfSandozUnknownPsoriasisDenmark, Spain, Germany, Poland
-
Mayo ClinicNational Cancer Institute (NCI)Recruiting
-
Jonsson Comprehensive Cancer CenterRecruitingEarly Stage Breast CarcinomaUnited States
-
Algalarrondo VincentBichat Hospital; BioquantisRecruitingTransthyretin Cardiac Amyloidosis | Transthyretin Amyloid Cardiomyopathy | Amyloid CardiomyopathyFrance
-
Mayo ClinicRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphatic System NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingPancreatic CarcinomaUnited States
-
Mayo ClinicRecruitingBreast Carcinoma | Recurrent Breast Carcinoma | Metastatic Breast CarcinomaUnited States
-
Mayo ClinicNot yet recruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Mayo ClinicRecruitingOropharyngeal Human Papillomavirus-Positive Squamous Cell CarcinomaUnited States
-
Mayo ClinicRecruitingBreast Cancer | Breast Carcinoma | Breast Cancer FemaleUnited States