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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Karnes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01098552
First received: April 1, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Biospecimen Retention:   Samples With DNA

Blood, urine, prostate tissue


Enrollment: 4900
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098552

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Director: R. J. Karnes, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert Karnes, Principal Manager, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01098552     History of Changes
Other Study ID Numbers: 1937-00, Mayo Clinic Prostate SPORE
Study First Received: April 1, 2010
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013