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Long-Term Follow-Up in Patients With Prostate Cancer After Surgery

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03035500
Collaborator
National Cancer Institute (NCI) (NIH)
2,500
Enrollment
1
Location
1
Arm
173
Anticipated Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Laboratory Biomarker Analysis
  • Other: Long-term Follow-up
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.

  2. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.

  3. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.

OUTLINE:

Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Long-term Follow-up After Prostate Cancer
Actual Study Start Date :
Jul 23, 2008
Anticipated Primary Completion Date :
Dec 23, 2022
Anticipated Study Completion Date :
Dec 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (long-term follow-up)

Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Other: Educational Intervention
Receive health education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Long-term Follow-up
    Undergo long-term follow-up using survivorship care plan

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. HRQL assessed using Expanded Prostate Cancer Index Composite [Up to 10 years]

      Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.

    2. HRQL assessed using Sexual Health Inventory for Men [Up to 10 years]

      Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends.

    3. Incidence rates of the study end-points [Up to 10 years]

      Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of prostate cancer

    • Treated with a definitive surgical procedure at City of Hope

    • At least one year post surgical treatment for prostate cancer

    • No history of recurrent, progressive, or metastatic disease

    • Currently stable disease or no evidence of disease

    • No prior treatment of prostate cancer with radiation or chemotherapy

    • No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer

    • Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician

    Exclusion Criteria:

    • Current treatment with testosterone replacement or androgen deprivation therapy

    • Treatment for another noncutaneous cancer within the past 2 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Saro Armenian, DO, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT03035500
    Other Study ID Numbers:
    • 07101
    • NCI-2017-00090
    • 07101
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 16, 2021