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Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02957357
Recruitment Status : Active, not recruiting
First Posted : November 7, 2016
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.

Brief Summary:
Through this study, the investigators seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies—every three vs. six vs. 12 months. Using the National Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the investigators aim to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies and compare quality-of-life outcomes. The overall goal of the study is to provide high-quality data that will allow development of a personalized, risk-based tailored approach to post-treatment surveillance for prostate cancer.

Condition or disease
Cancer of Prostate Cancer of the Prostate Prostate Cancer Prostatic Cancer

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Study Type : Observational
Estimated Enrollment : 14000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mortality (all cause) [ Time Frame: 2-10 Years after treatment ]

Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: 2-10 Years after treatment ]
  2. Treatment for recurrent cancer [ Time Frame: 2-10 Years after treatment ]

Other Outcome Measures:
  1. Patient-reported anxiety [ Time Frame: 2-10 Years after treatment ]
  2. Health-related quality of life [ Time Frame: 2-10 Years after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 14,000 prostate cancer patients in the National Cancer Data Base (nationwide cancer registry) will be analyzed.

The investigators will analyze data from the National Cancer Data Base (NCDB), a cancer registry which is maintained by the American College of Surgeons Commission on Cancer (CoC). Cancer registry staff review hospital and provider records to collect necessary data for the cancer registry so data are available for analysis for this project. There are >1400 CoC-hospitals; 10 patients will be sampled at each hospital thus 14,000 patients will be available for analysis.

Criteria

Inclusion Criteria:

  • Patient data part of the NCDB
  • Diagnosed with prostate cancer in 2004-2005.
  • Treated for prostate cancer with surgery (prostatectomy) or radiation therapy

Exclusion Criteria:

-


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Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT02957357     History of Changes
Other Study ID Numbers: AFT-30
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to share data or to make individual participant data available.
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases