Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up

Prostate Cancer Clinical Trial

Official title:

Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098552
• Other study ID #: 1937-00
• Secondary ID: Mayo Clinic Pros
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: January 9, 2013
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4900
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent explained and signed prior to any study related procedures.

2. Age =18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, or Karnofsky performance of 60% or better.

4. Histologically confirmed adenocarcinoma of the prostate within 10 years of study entry.

5. Willingness to return to Mayo Clinic Rochester for follow-up or participate in mail-in PSA processing.

6. Must be disease-free from a previous diagnosis of cancer for a period of time = 5 years excluding cutaneous malignancies of squamous cell or basal cell carcinoma.

Exclusion Criteria:

1. Life expectancy < 5 years.

2. Inability to return to Mayo Rochester for follow-up appointments, sera, and urine collection per protocol.

3. Previous or a concurrent diagnosis of cancers other than basal cell or invasive squamous cell carcinoma of skin within the past 5 years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,