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

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ClinicalTrials.gov Identifier: NCT03035500
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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
Cancer Survivor Prostate Carcinoma Other: Educational Intervention Other: Laboratory Biomarker Analysis Other: Long-term Follow-up Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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

II. 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.

III. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long-term Follow-up After Prostate Cancer
Study Start Date : July 2008
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. HRQL assessed using Expanded Prostate Cancer Index Composite [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035500


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Saro Armenian, DO City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03035500     History of Changes
Other Study ID Numbers: 07101
NCI-2017-00090 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
07101 ( Other Identifier: City of Hope Medical Center )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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