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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: Prostate cancer screening for Prostatic Neoplasm

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and measure the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Official registry: https://clinicaltrials.gov/study/NCT05129605 · Massachusetts General Hospital · enrollment listed as 400

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 400 people at Boston. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Interventions: Prostate cancer screening

Primary outcome (registry wording): Diagnosis of prostate cancer

Who it is for (from inclusion criteria)

  • Ages 35 Years to any
  • Men only
  • Individuals with a prostate aged 35 years or older
  • No known diagnosis of prostate cancer
  • Life expectancy \>10 years
  • Meet cohort A, B, or C criteria
  • Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
  • Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
  • Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Public study contact (from the registry)

Olympia Price

857-238-3838

oprice@partners.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT05129605 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05129605?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05129605?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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