Recruiting

Prostate Cancer Detection

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07645391

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.

Conditions

Prostate Carcinoma

Study ID

NCT07645391

Start date

Jan 1, 2017

Status verified date

Jun, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 35 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • \* Age 35-70 years

  • Capable of providing informed consent
  • Prognosis of > 5 years if affected by another cancer
  • Patients need one to meet at least one of the following high genetic risk categories:

  • Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53
  • Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13
  • Obligate carriers of the above mutations (e.g. their sisters/daughters have known mutations)
  • Men with any family history of above mutation
  • Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50

Exclusion Criteria:

  • \* Anuria

  • Prior diagnosis or treatment for PCa
  • Failure to provide informed consent
  • Life expectancy < 5 years

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo urine and blood sample collection, provide family history of cancer and have their medical records reviewed throughout the study. Patients also undergo a digital rectal examination, complete a questionnaire and receive results of the PSA blood test and urine biomarker test. Patients with an elevated PSA level above 2.0 ng/ml (age 40-49) or 2.5 ng/ml (age 50-70) or abnormal urine test will be referred for an ultrasound-guided biopsy of the prostate gland.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Predictors of any HG PCa [ Time Frame: At 5-years follow up ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

1-800-865-1125CancerAnswerLine@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Todd M. Morgan, MD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-06-12.