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

NCT01098552 | Completed

• 2 other identifiers: 1937-00Mayo Clinic Prostate SPORE
• Study Type: observational
• Target: 4,900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Study Arms (6)

High-risk radical prostatectomy patients

Primary external beam radiotherapy patients

Primary prostate brachytherapy patients

Hormone refractory prostate cancer patients

Active Surveillance

Prostate biopsy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are six patient cohorts which are being recruited to the Prostate Clinical Follow-up Core in support of the Specialized Program of Research Excellence (SPORE). The six groups are: 1. High-risk radical prostatectomy patients, 2. Primary external beam radiotherapy patients, 3. Primary prostate brachytherapy patients, 4. Hormone refractory prostate cancer patients, 5. Active Surveillance. 6. Prostate biopsy patients. The inclusion criterion for group 6 is that the patient is scheduled to undergo a prostate biopsy for the purposes of definitive prostate cancer diagnosis. There are no exclusion criteria for group 6.

You may qualify if:

• Informed consent explained and signed prior to any study related procedures.
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, or Karnofsky performance of 60% or better.
• Histologically confirmed adenocarcinoma of the prostate within 10 years of study entry.
• Willingness to return to Mayo Clinic Rochester for follow-up or participate in mail-in PSA processing.
• 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.

You may not qualify if:

• Life expectancy \< 5 years.
• Inability to return to Mayo Rochester for follow-up appointments, sera, and urine collection per protocol.
• Previous or a concurrent diagnosis of cancers other than basal cell or invasive squamous cell carcinoma of skin within the past 5 years.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, prostate tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• R. J. Karnes, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Manager

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

US (1)