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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

April 1, 2010
January 9, 2013
February 2010
November 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01098552 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, urine, prostate tissue

Non-Probability Sample

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.

Prostate Cancer
Not Provided
  • High-risk radical prostatectomy patients
  • Primary external beam radiotherapy patients
  • Primary prostate brachytherapy patients
  • Hormone refractory prostate cancer patients
  • Active Surveillance
  • Prostate biopsy patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4900
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01098552
1937-00, Mayo Clinic Prostate SPORE
No
Robert Karnes, Mayo Clinic
Mayo Clinic
Not Provided
Study Director: R. J. Karnes, MD Mayo Clinic
Mayo Clinic
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP