Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer

Institute of Cancer Research, United Kingdom

Status: Unknown

Conditions: Prostate Cancer

Treatments: Other: laboratory biomarker analysis; Other: questionnaire administration; Other: medical chart review

Study type: Observational

Funder types: Other

Identifiers

NCT00959023

CDR0000636371

EU-20909

ICR-UKGPCS

Details and patient eligibility

About

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited risk of prostate cancer.

Full description

OBJECTIVES:

• To find genes that predispose to prostate cancer (using genetic linkage and other molecular biology techniques).
• To determine if genes that predispose to prostate cancer are associated with disease and treatment parameters.
• To determine if genes that predispose to prostate cancer are associated with environmental factors.
• To estimate the percentage of prostate cancer patients who have a positive family history of the disease.
• To estimate the relative risk of developing prostate cancer in a currently unaffected member of a prostate cancer family.
• To ascertain whether relatives of prostate cancer patients are at increased risk of developing cancers other than prostate cancer.
• To build up a large blood and tumor (both fresh and preserved) bank from patients with prostate cancer to identify prostate cancer predisposition gene(s), determine the prevalence and penetrance of prostate cancer predisposition genes in prostate cancer patients, correlate changes in prostate cancer predisposition gene(s) with disease and treatment parameters by matching with clinical data from clinical databases already held as part of the medical record on these patients, and correlate changes in prostate cancer predisposition gene(s) with environmental factors collected by questionnaire from these patients.
• To use the blood and tumor bank for marker studies (DNA, RNA, serum, plasma, protein, and other molecules) to define the role of these markers in disease prediction and progression.
• To develop microarrays from prostate cancers to determine their genetic profile and correlate this with prostate cancer genetic predisposition genes.
• To collect tissue from other unaffected and affected members of the family in cases where a genetic alteration is found, in order to ascertain whether this alteration is associated with disease risk.
• To collect tissue samples from unaffected family members who show an interest in taking part in the study.

OUTLINE: Patients are assessed by a family history and epidemiology questionnaire and undergo a medical record review.

Patients and relatives with prostate cancer may undergo blood sample collection for genetic analysis of prostate cancer predisposition genes and measurement of markers of associations with genetic changes associated with prostate cancer. Blood and tumor samples are stored for future studies.

Enrollment: 21,000 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

  • Diagnosis of prostate cancer meeting any of the following criteria:

    • Attending prostate clinics at The Royal Marsden NHS Foundation Trust

      • Any age at diagnosis

    • Not attending prostate clinics at The Royal Marsden NHS Foundation Trust, meeting 1 of the following criteria:

      • No older than 60 years at diagnosis
      • Diagnosis in two relatives where one is ≤ 65 years at diagnosis
      • At any age in a cluster with 3 or more cases

  • Any unaffected male relatives of men who are already taking part in the study

PATIENT CHARACTERISTICS:

• Able to understand the information sheet and give informed consent
• No man who is too ill to take part

PRIOR CONCURRENT THERAPY:

• Not specified