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Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954004
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Tracking Information
First Submitted Date September 26, 2013
First Posted Date October 1, 2013
Last Update Posted Date June 2, 2015
Study Start Date April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2013)
Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®). [ Time Frame: 4 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2013)
  • Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation) [ Time Frame: 1 month ]
  • Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient. [ Time Frame: 2 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2013)
• The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing. [ Time Frame: 4 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients
Official Title An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients
Brief Summary This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2015)
1270
Original Estimated Enrollment
 (submitted: September 26, 2013)
1100
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
  • Clinically localized (no evidence on clinical or imaging studies of advanced disease).
  • No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
  • Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

  • Patients with a known history of hypogonadism
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01954004
Other Study ID Numbers PROCEDE-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Myriad Genetic Laboratories, Inc.
Original Responsible Party Same as current
Current Study Sponsor Myriad Genetic Laboratories, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Richard Wenstrup, MD Myriad Genetic Laboratories, Inc.
PRS Account Myriad Genetic Laboratories, Inc.
Verification Date May 2015